Fluid delivery system, fluid path set, and pressure isolation mechanism with hemodynamic pressure dampening correction

ABSTRACT

A fluid delivery system which includes a pressurizing device for delivering injection fluid under pressure, a low pressure fluid delivery system, and a pressure isolation mechanism. The pressure isolation mechanism includes a valve housing having a first port associated with the pressurizing device, a second port associated with the low pressure fluid delivery system, an outlet port associated with a patient, and a pressure isolation port for connection with a pressure transducer. A first valve in a normally open position permits fluid communication between the first port and the second port and is movable to a closed position when fluid pressure in the first port increases to a predetermined pressure level. The first valve isolates the pressure isolation port from the first port when in the closed position. A second valve is associated with the second port and regulates fluid flow through the second port.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is division of application Ser. No. 11/551,027, filedon Oct. 19, 2006, now abandoned, which is a continuation-in-part ofapplication Ser. No. 11/004,670, filed on Dec. 3, 2004, now U.S. Pat.No. 8,540,698, which is a continuation-in-part of application Ser. No.10/826,149, filed on Apr. 16, 2004, now U.S. Pat. No. 7,611,503, thedisclosures of which are incorporated herein by reference.

RELATED APPLICATIONS

This application may contain subject matter that is related to thatdisclosed in the following applications: (1) application Ser. No.10/818,748, filed on Apr. 6, 2004, now U.S. Pat. No. 7,326,186; (2)application Ser. No. 10/818,477, filed on Apr. 5, 2004, now U.S. Pat.No. 7,563,249; (3) application Ser. No. 10/326,582, filed on Dec. 20,2002, now U.S. Pat. No. 7,549,977; (4) application Ser. No. 10/237,139,filed on Sep. 6, 2002, now U.S. Pat. No. 6,866,654; and (5) applicationSer. No. 09/982,518, filed on Oct. 18, 2001, now U.S. Pat. No.7,094,216, the disclosures of which are incorporated herein byreference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to fluid delivery systems forsupplying fluids during medical diagnostic and therapeutic procedures,further, to fluid transfer sets and flow controlling and regulatingdevices associated therewith used with fluid delivery systems forconducting and regulating fluids flows.

2. Description of Related Art

In many medical diagnostic and therapeutic procedures, a physician orother person injects a patient with a fluid. In recent years, a numberof injector-actuated syringes and powered injectors for pressurizedinjection of fluids, such as contrast media, have been developed for usein procedures such as angiography, computed tomography, ultrasound, andNMR/MRI. In general, these powered injectors are designed to deliver apreset amount of contrast media at a preset flow rate.

Angiography is used generally in the detection and treatment ofabnormalities or restrictions in blood vessels. In an angiographicprocedure, a radiographic image of vascular structure is obtainedthrough the use of a radiographic contrast medium, sometimes referred tosimply as contrast, injected through a catheter. The vascular structuresin fluid connection with the vein or artery in which the contrast isinjected are filled with contrast. X-rays passing through the region ofinterest are absorbed by the contrast, causing a radiographic outline orimage of blood vessels containing the contrast. The resulting images canbe displayed on, for example, a monitor and recorded.

In a typical angiographic procedure, a physician places a cardiaccatheter into a vein or artery. The catheter is connected to either amanual or to an automatic contrast injection mechanism. A typical manualcontrast injection mechanism, as illustrated, for example, in FIG. 1,includes a syringe in fluid connection with a catheter connection. Thefluid path also includes, for example, a source of contrast fluid, asource of saline, and a pressure transducer P to measure patient bloodpressure. In a typical system, the source of contrast is connected tothe fluid path via a valve V¹, for example, a three-way stopcock. Thesource of saline and pressure transducer P may also be connected to thefluid path via additional valves V² and V³, respectively. The operatorof the manual system of FIG. 1, manually controls the syringe and eachof the valves V¹ and V² to draw saline or contrast into the syringe andto inject the saline or contrast into the patient through the catheterconnection. The pressure transducers used in such procedures areextremely sensitive to even moderately high pressures generated duringactivation of the syringe, so the operator must close valve V³ toisolate pressure transducer P from the fluid path when the syringe isactivated to prevent damage to pressure transducer P. While the syringeis not activated, valve V³ is usually open to monitor patient bloodpressure.

The operator of the syringe of FIG. 1 may adjust the flow rate andvolume of injection by altering the force applied to the plunger of thesyringe. Manual sources of fluid pressure and flow used in medicalapplications such as syringes and manifolds thus typically requireoperator effort that provides feedback of the fluid pressure/flowgenerated to the operator. The feedback is desirable, but the operatoreffort often leads to fatigue. Thus, fluid pressure and flow may varydepending on the operator's strength and technique.

Automatic contrast injection mechanisms typically include a syringeconnected to a powered injector having, for example, a powered linearactuator. Typically, an operator enters settings into an electroniccontrol system of the powered injector for a fixed volume of contrastmaterial and a fixed rate of injection. In many systems, there is nointeractive control between the operator and the powered injector,except to start or stop the injection. A change in flow rate in suchsystems occurs by stopping the machine and resetting the parameters.Automation of angiographic procedures using powered injectors isdiscussed, for example, in U.S. Pat. Nos. 5,460,609, 5,573,515 and5,800,397.

U.S. Pat. No. 5,800,397 discloses an angiographic injector system havinghigh pressure and low pressure systems. The high pressure systemincludes a motor-driven injector pump to deliver radiographic contrastmaterial under high pressure to a catheter. The low pressure systemincludes, among other things, a pressure transducer to measure bloodpressure and a pump to deliver a saline solution to the patient as wellas to aspirate waste fluid. A manifold is connected to the syringe pump,the low pressure system, and the patient catheter. A flow valveassociated with the manifold is normally maintained in a first stateconnecting the low pressure system to the catheter through the manifold,and disconnecting the high pressure system from the catheter and the lowpressure system. When pressure from the syringe pump reaches apredetermined and set level, the valve switches to a second stateconnecting the high pressure system/syringe pump to the catheter, whiledisconnecting the low pressure system from the catheter and from thehigh pressure system. In this manner, the pressure transducer isprotected from high pressures, (see column 3, lines 20-37 of U.S. Pat.No. 5,800,397). However, compliance in the system components, forexample, expansion of the syringe, tubing, and other components underpressure, using such a manifold system can lead to a less than optimalinjection bolus. Moreover, the arrangement of the system components ofU.S. Pat. No. 5,800,397 results in relatively large amounts of wastedcontrast and/or undesirable injection of an excessive amount of contrastwhen the low pressure, typical saline system, is used. The injectorsystem of U.S. Pat. No. 5,800,397 also includes a handheld remotecontrol connected to a console. The control includes saline push buttonswitches and a flow rate control lever or trigger. By progressivesqueezing of the control trigger, the user provides a command signal tothe console to provide a continuously variable injection ratecorresponding to the degree of depression of the control trigger.

U.S. Pat. No. 5,916,165 discloses a handheld pneumatic controller forproducing a variable control signal to control a rate of fluiddispersion to the patient in an angiographic system. U.S. Pat. No.5,515,851 discloses an angiographic system with a finger activatedcontrol pad to regulate the injection of fluids.

Unlike manual injection systems, however, there is little if anyfeedback to the operator of system pressure in the systems disclosed inthe U.S. patents identified previously. There are potential advantagesto such feedback. In the use of a manual syringe, for example, excessiveback pressure on the syringe plunger can provide evidence of occlusionof the fluid path.

U.S. Pat. No. 5,840,026 discloses, an injection system in which anelectronic control system is connected to the contrast delivery systemand a tactile feedback control unit. In one embodiment, the tactilefeedback control unit includes a disposable syringe that is locatedwithin a durable/reusable cradle and is in fluid connection with thefluid being delivered to the patient. The cradle is electricallyconnected to the electronic control system and is physically connectedto a sliding potentiometer that is driven by the plunger of a disposablesyringe. During use of the injection system of U.S. Pat. No. 5,840,026,the operator holds the cradle and syringe and, as the operator depressesthe sliding potentiometer/syringe piston assembly, the plunger is movedforward, displacing fluid toward the patient and creating a pressure inthe syringe. A sliding potentiometer tracks the position of the syringeplunger. The electronic control system controls the contrast deliverysystem to inject an amount of fluid into the patient based on the changein position of the plunger. As the fluid is injected, the pressure theoperator feels in his or her hand is proportional to the actual pressureproduced by the contrast delivery system. The force required to move thepiston provides the operator with tactile feedback on the pressure inthe system. The operator is able to use this feedback to ensure thesafety of the injection procedure. Unlike the case of a manual injectionsystem, the injection system of U.S. Pat. No. 5,840,026 does not requirethe operator to develop the system pressure and flow rate. The operatordevelops a smaller, manually applied pressure that corresponds to or isproportional to the system pressure. The required manual power output(that is, pressure×flow rate) is decreased as compared to manualsystems, whereas the tactile feedback associated therewith is retained.

While manual and automated injectors are know in the medical field, aneed generally exists for improved fluid delivery systems adapted foruse in medical diagnostic and therapeutic procedures where fluids aresupplied to a patient during the procedure. A specific need generallyexists for an improved fluid delivery system for use in fluid injectionprocedures, such as angiography. Additionally, a need generally existsfor fluid transfer sets and flow controlling and regulating devicesassociated therewith that may be used with fluid delivery systems forconducting and regulating fluids flows. Moreover, a continuing needexists in the medical field to generally improve upon known medicaldevices and systems used to supply fluids to patients during medicalprocedures such as angiography, computed tomography, ultrasound, andNMR/MRI.

SUMMARY OF THE INVENTION

The present invention provides an injector system including a poweredinjector, a pressurizing chamber in operative connection with thepowered injector, a fluid path in fluid connection with the pressurizingchamber, and a manual control in fluid connection with the fluid path.The manual control includes at least one actuator for controlling theinjector through application of force by an operator. The actuatorprovides tactile feedback of pressure in the fluid path to the operatorvia direct or indirect operative or fluid connection with the fluid path(i.e., pressure in the fluid path transfers a corresponding or aproportional force to the operator). In one embodiment, the actuator isadapted to stop an injection procedure if no force is applied to theactuator. The manual control may, for example, include a chamber influid connection with the fluid path. The actuator may be a button or aplunger in operative connection with a piston disposed within thechamber. The actuator may be biased in an off position.

In another aspect, the manual control includes a first actuator forcontrolling the injector in a low pressure mode through application offorce by an operator. The first actuator provides tactile feedback ofpressure in the fluid path to the operator via fluid connection with thefluid path as described previously. The first actuator also providescontrol of flow rate by changing the force thereon. The manual controlalso may include a second actuator having an on state and an off state.The second actuator causes the injector to enter into a preprogrammedhigh-pressure injection mode when placed in the on state. The manualcontrol may also include a third actuator for controlling flow of salinein the fluid path.

In another aspect of the present invention, the actuator providestactile feedback of fluid pressure and is also in operative connectionwith an audible feedback unit that provides audible feedback of fluidpressure and/or fluid flow to the operator. The manual controls of thepresent invention may be purged of air before injection via, forexample, a purge valve.

The present invention also provides a system for injection of fluid intoa patient including a multi-patient reusable section and a per-patientdisposable section. The multi-patient reusable section and theper-patient disposable section are removably connectable via a connectoror connectors, for example, via a high-pressure connector. Themulti-patient reusable section includes a powered injector in fluidconnection with a source of a first injection fluid and a first fluidpath connecting the injector and a high-pressure connector. Theper-patient disposable section includes a second fluid path adapted toconnect the high-pressure connector and the patient in fluid connection.The per-patient disposable section further includes a manual control asdescribed above including a connector to place the manual control influid connection with the second fluid path. The multi-patient reusablesection may further include a valve mechanism connecting the injector,first fluid source, and the first fluid path.

In one embodiment, the multi-patient reusable section further includes asource of a second injection fluid and a pumping mechanism in fluidconnection with the second fluid source for pressurizing the secondfluid. The pumping mechanism is preferably in fluid connection with thevalve mechanism.

In one aspect, the manual control includes a first actuator providingcontrol of flow rate of the first fluid by changing the force on thefirst actuator and a second actuator, the second actuator causing theinjector to enter into a preprogrammed high pressure injection mode whenplaced in an on state. The system may further include a pressure sensorin fluid communication with the second fluid path via apressure-activated isolator that isolates the pressure sensor frompressures in the second fluid path above a set pressure. In oneembodiment, the per-patient disposable section may include a check valvein the second fluid path separating components of the per-patientdisposable section from the multi-patient reusable section to reduce oreliminate flow of contaminated fluid into the multi-patient reusablesection.

The present invention further provides a method of injecting a fluidinto a patient including the steps of: removably connecting amulti-patient reusable section to a per-patient disposable section via ahigh-pressure connector, the multi-patient reusable section including apowered injector in fluid connection with a source of a first injectionfluid and a first fluid path connecting the injector and thehigh-pressure connector, the per-patient disposable section including asecond fluid path adapted to connect the high-pressure connector and thepatient in fluid connection; connecting a manual control including aconnector to the second fluid path to place the manual control in fluidconnection with the second fluid path, the manual control including atleast one actuator for controlling the powered injector throughapplication of force by an operator, the actuator being adapted toprovide tactile feedback of pressure in the second fluid path to theoperator via fluid connection with the second fluid path; and injectinga fluid into a patient.

The method may further include the step of connecting a pressure sensorin fluid communication with the second fluid path via a pressureactivated isolator that isolates the pressure sensor from pressures inthe second fluid path above a set pressure.

Still further, the present invention provides a per-patient disposableset for use in an injection procedure including a fluid path adapted toform a fluid connection between a high-pressure connector and thepatient, and a manual control in fluid connection with the fluid path.The manual control includes at least one actuator for controlling thepowered injector through application of force by an operator. Theactuator is adapted to provide tactile feedback of pressure in the fluidpath to the operator via fluid connection with the fluid path. Theper-patient disposable set further includes a pressure sensor in fluidconnection with the fluid path via a pressure activated isolator adaptedto isolate the pressure sensor from pressures in the fluid path above aset pressure.

The manual, for example, handheld controllers of the present inventionprovide a number of advantages including, but not limited to thefollowing: tactile feedback of actual fluid path pressure via fluidcommunication with the fluid path, compact size and small primingvolume; dead man switch capability; ergonomic design for control of bothcontrast and saline; injection pressure feedback linked to variable flowand audible feedback; rigid material construction; actuator controlproviding a progressively increasing flow rate as the actuator is pushedor depressed through its range of motion; and high-pressure injectionsthat are greater in pressure than could be generated or tolerated by anoperator's hand.

In another aspect, the present invention provides an injection systemfor use in angiography including a powered injector in fluid connectionwith a source of injection fluid and a pressure sensor in fluidconnection with the powered injector via a pressure activated isolatoradapted to isolate the pressure sensor from pressures in the fluid pathabove a set pressure. The pressure sensor elevation is independent of orindependently variable of the position of the remainder of the injectionsystem, including the position or elevation of the powered injector.

In a further aspect, the present invention provides an angiographicinjection system for injecting an injection fluid into a patientincluding a pressurizing device for supplying injection fluid underpressure; a low pressure fluid delivery system; and a pressure isolationmechanism having a first port for connection to the pressurizing device,a second port for connection to the patient, and a third port forconnection to the low pressure fluid delivery system. The pressureisolation mechanism includes a valve having a first state and a secondstate different from the first state. Preferably, the first state andthe second state are mutually exclusive of each other. The first stateoccurs when the second and third ports are connected and the first andthird ports are connected. The second state occurs when the first andsecond ports are connected and the first and third ports aredisconnected. The valve is normally biased to the first state via, forexample, a spring, and is switchable to the second state when fluidpressure from the syringe pump reaches a predetermined pressure level.The first and second ports remain connected in the first state and inthe second state.

The system preferably further includes a valve in line between thepressurizing device and the first port of the pressure isolationmechanism to control flow of the injection fluid. Preferably, the valveis an automated valve. The valve is preferably operable to minimize oreliminate the effects of compliance of the pressurizing device andrelated tubing.

The low pressure delivery system may include a source of saline or othersuitable flushing medium, a drip chamber in fluid connection with thesource of saline, and a detector to sense the amount of saline in thesource of saline. The system may further include a saline control valveand an air detector in line between the saline drip chamber and thepressure isolation mechanism.

The pressurizing device may be in fluid connection with a source ofinjection fluid via an injection fluid drip chamber. The system mayfurther include a detector to sense the amount of injection fluid in thesource of injection fluid. Likewise, the system may also include aninjection fluid control valve and an air detector in line between theinjection fluid drip chamber and the pressure isolation mechanism.

In one embodiment, the system further includes a handheld controller tocontrol injection of injection fluid and injection of saline. Thehandheld controller may include a first control having a first mode tocontrol injection of injection fluid in a low pressure mode, the flowrate of the injection corresponding to, for example, being proportionalto, the distance the first control is depressed. Preferably, the lowpressure injection is ceased if the first control is released while inthe first mode. The first control may, for example, have a second modeto control injection of injection fluid in a high pressure mode. Thehigh pressure mode injection is preferably ceased if the first controlis released while in the second mode. The hand controller may furtherinclude at least a second control to control injection of saline.Preferably, the injection of saline is ceased if the second control isreleased during injection of saline.

The system preferably further includes a pressure transducer in fluidconnection with the third port of the pressure isolation mechanism.

In still a further aspect, the present invention provides an injectionsystem for use in angiography including a source of saline, a pump influid connection with the source of saline to pressurize the saline, asaline valve in fluid connection via a first port thereof with an outletof the pump, a first connector in fluid connection with a second port ofthe saline valve, a source of contrast, a contrast valve in fluidconnection with the source of contrast via a first port of the contrastvalve, a powered injector in fluid connection with a second port of thecontrast valve, a second connector in fluid connection with a third portof the contrast valve, and a pressure isolation mechanism.

The pressure isolation mechanism has a lumen having a first port influid connection with the second connector and a second port in fluidconnection with a patient catheter. The isolation mechanism further hasa third port in fluid connection with the first connector and with thelumen. The pressure isolation mechanism further includes a valve havinga first state and a preferably mutually exclusive second state—the firststate occurring when the lumen and the third port are connected, and thesecond state occurring when the lumen and the third port aredisconnected. The valve is preferably normally biased to the first stateand is switchable to the second state when fluid pressure from thepowered injector reaches a predetermined pressure level. The first andsecond ports of the lumen preferably remain connected whether in thefirst state or in the second state. The system further includes apressure transducer in fluid connection with the third port of thepressure isolation mechanism.

The system may also include a first air or air column detector in fluidconnection between the saline valve and the first connector and a secondair detector in fluid connection between the contrast valve and thesecond connector.

The system may also include a first drip chamber in fluid connectionbetween the source of saline and the pump and a detector in operativeconnection with the first drip chamber to sense the amount of saline inthe source of saline. Likewise, the system may include a second dripchamber in fluid connection between the source of contrast and thecontrast valve and a detector in operative connection with the seconddrip chamber to sense the amount of injection fluid in the source ofinjection fluid. One advantage of a drip chamber is to reduce likelihoodof introduction of air into the system once the system has beeninitially purged of air or primed.

In another aspect, the present invention provides a pressure isolationmechanism for use in a medical procedure. The pressure isolationmechanism or pressure isolator includes a lumen, an isolation port influid connection with lumen, and a valve having a first state and asecond state. The first state occurs when the lumen and the isolationport are connected. The second state occurs when the lumen and theisolation port are disconnected. The lumen remains open for flow offluid therethrough in the first state and in the second state. The valveis normally in the first state and is switchable to the second statewhen fluid pressure in the lumen reaches a predetermined pressure level.The valve may, for example, be biased to the first state, for example,via a spring or other mechanism suitable to apply a biasing force asknown in the art. A pressure sensor or transducer can be in fluidconnection with the isolation port of the pressure isolation mechanismas described previously.

The valve may be switched between the first state and the second stateby the force of the fluid pressure. Alternatively, an electromechanicalactuator in operative connection with a pressure sensor may control thestate of the valve as a function of the fluid pressure. The pressuresensor may, for example, be a pressure transducer in fluid connectionwith the isolation port as described previously.

In general, the pressure isolation mechanism is useful in any medicalprocedure in which is it desirable to isolate a fluid pathway or fluidpath component from fluid flow above a certain fluid pressure. The fluidpathway or fluid path component is placed in fluid connection with theisolation port of the pressure isolation mechanism. For example, apressure transducer may be placed in connection with the isolation portto protect the pressure transducer form damage as a result of exposureto excess fluid pressure.

In a further aspect, the present invention provides a fluid deliverysystem including a manually operated syringe and a pressure isolationmechanism as described above.

The present invention provides in another aspect a method of adding apatient pressure transducer to a fluid path used in a medical procedureto deliver fluid to a patient. The method includes the step of placing alumen of a pressure isolation mechanism as described above in the fluidpath via, for example, a first port and a second port of the lumen. Themethod also includes the steps of connecting a pressure transducer tothe third or isolation port of the pressure isolation mechanism. Themethod is useful, for example, in adding a patient pressure transducerto an angiographic fluid delivery system including a manual syringe.

The present invention is further directed to a fluid path set for usegenerally in a fluid delivery system. The fluid path set generallyincludes a first section generally adapted for association with apressurizing device such as a syringe, and a second section adapted forremovable fluid communication with the first section. The first sectionmay be a multi-patient section of the fluid path set, and the secondsection may be a single or per-patient section of the fluid path set andbe disposable after use with a single patient. The multi-patient sectionmay be disposable after a preset number of uses with the fluid deliverysystem. Additionally, the multi-patient section may be provided as asingle patent set or section, disposed of after use with a singlepatient or injection procedure. Further, it is within the scope of thepresent invention to provide the first and second sections of the fluidpath set as multi-use components that may be re-sterilized after eachuse or injection procedure. The first section may be adapted forconnection to a source of fluid to be loaded into a pressurizing device.The first section may comprise a multi-position valve adapted toselectively isolate the fluid source and the second section.

Another aspect of the present invention is directed to a connector foruse in a fluid delivery or transfer system or arrangement, and generallyadapted to reduce the likelihood of contamination at connection pointsin the fluid path set when changing components in the fluid path set.The connector may be used with the fluid path set for providingremovable fluid communication between the first section and the secondsection. The connector is configured to reduce contamination whenconnecting one or more typically disposable second sections with atypically multiple-patient first section in the fluid path set. Theconnector generally includes a first connector member and a secondconnector member, which are generally adapted to removably connect withone another. The first and second connector members may be associatedwith either the first section or the second section. Thus, if the firstconnector member is associated with the first section, the secondconnector member is associated with the second section, and vice versa.The first connector member includes an outer housing and a firstthreaded member disposed in the outer housing. The second connectormember includes a second threaded member. The first threaded member andsecond threaded member cooperate to securely and releasably connect thefirst member to the second member, when the first connector member isconnected to the second connector member. The connection of the firstconnector member with the second connector member generally establishesthe removable fluid communication between the first section and thesecond section, when the connector is used therewith. The secondthreaded member is preferably received in the outer housing of the firstconnector member when the first connector member is connected to thesecond connector member.

The first threaded member may be recessed within the outer housing. Thefirst threaded member may be formed as an externally-threaded luer,which may be recessed within the outer housing. The second member mayinclude a luer disposed in the second threaded member and adapted tocooperate with the first threaded member. The luer may be recessedwithin the second threaded member.

The first threaded member may be formed as an externally-threaded femaleluer, and the second member may include a male luer disposed in thesecond threaded member, such that the male luer cooperates with thefemale luer when the first connector member is connected to the secondconnector member. One or both of the female luer and the male luer maybe recessed within the outer housing and the second threaded member,respectively.

The first threaded member may be externally-threaded and the secondthreaded member may be internally-threaded. The second threaded membermay include at least one circumferentially-extending raised structure onan external surface thereof. The raised structure may define a tortuouspath with an inner wall of the outer housing for inhibiting liquid flowbetween the outer housing and the second threaded member when the firstconnector member is connected to the second connector member. The raisedstructure may define a chamber with the inner wall of the outer housingand the first threaded member when the first connector member isconnected to the second connector member.

Protective caps may be associated with the first connector member andthe second connector member, respectively, prior to connecting the firstconnector member and the second connector member. The first and secondconnector members may each include a raised tab adapted to cooperatewith a corresponding groove defined internally in the protective caps,for securing removable engagement between the first and second connectormembers and the respective protective caps. The protective caps may bedisposable or reusable items.

An additional aspect of the present invention is directed to a pressureisolation mechanism that may be used, for example, with the fluid pathset. For example, the second section of the fluid path set may includethe pressure isolation mechanism. The pressure isolation mechanismgenerally comprises a lumen, a pressure isolation port, and a valvemember. The valve member includes a biasing portion biasing the valvemember to a normally open position permitting fluid communicationbetween the lumen and the pressure isolation port. The valve member ismovable to a closed position when fluid pressure in the lumen reaches apredetermined pressure level sufficient to overcome the biasing force ofthe biasing portion of the valve member.

The pressure isolation mechanism may have a housing that defines thelumen and the pressure isolation port. A pressure transducer may beassociated with the pressure isolation port. The valve member maycomprise a seat member and a base portion engaged with the seat member.The biasing portion of the valve member may be a generally cone-shapedportion of the seat member. The generally cone-shaped portion preferablyhas a predetermined spring force. The seat member may be adapted toengage a housing of the pressure isolation mechanism in the closedposition of the valve member. The seat member may define an aperture andthe base portion may be formed with a projection engaged with theaperture for connecting the base portion to the seat member. The baseportion may be joined to the seat member by mechanical connectiontherewith or bonded to the seat member, for example with an adhesive.

The pressure isolation mechanism may have a multi-piece housing, such asa two-piece housing including a first portion cooperating with a secondportion. The first portion may be in an interference fit engagement withthe second portion. The first portion and second portion may be formedto define a tortuous or shear interface therebetween to enhancestrength.

A still further aspect of the present invention is directed to animproved drip chamber that may be used as part of the fluid path set.For example, one or more drip chambers may be used with the firstsection, or the second section. In one embodiment, the first sectionincludes an intervening drip chamber between the primary fluid sourceand the syringe. The drip chamber generally comprises a projectionuseful for determining a level of fluid in the drip chamber. Theprojection is preferably raised from the body of the drip chamber, andmay extend longitudinally or laterally along the body of the dripchamber.

Additionally, the first section may be adapted for connection to asecondary source of fluid to be delivered to a patient, such as saline.An intervening drip chamber may also be associated with the secondaryfluid source and the first section. The drip chamber associated with thesecondary fluid source preferably also has a projection for determininga level of fluid in the drip chamber, which is also preferably raisedfrom the body of the drip chamber. The second section may be furtheradapted for removable fluid communication with the first section, suchthat the secondary fluid source is in fluid communication with thepressure isolation port. The intervening drip chamber associated withthe secondary fluid source may be located between the secondary fluidsource and the pressure isolation port.

The present invention is further directed as a method of preparing afluid delivery system for association with a patient. The methodgenerally includes providing the fluid delivery system including aninjector, associating a syringe with the injector, and providing thefluid path set comprising the first section and the second section. Thefirst section may be connected with the syringe, and the second sectionconnected to the first section to provide removable fluid communicationtherebetween.

The first section may be removably connected to the second section withthe connector described previously. The second section is generallyplaced in removable fluid communication with the first section byconnecting the first connector member and the second connector member ofthe connector. The second threaded member of the second connector isreceived in the outer housing of the first connector member when thefirst connector member and second connector member are connected.

Additionally, the present invention is a method of delivering fluid to apatient, generally providing a fluid delivery system including aninjector, associating a syringe with the injector, and providing thefluid path set comprising the first section and the second section. Thefirst section may be connected with the syringe, and the second sectionconnected to the first section to provide removable fluid communicationtherebetween. The second section may then be connected to the patientand the injector actuated to deliver fluid to the patient. When thefluid delivery procedure is complete, the injector may be deactivated toterminate delivery of fluid to the patient, and the second section ofthe fluid path set may be disconnected from the patient.

The first section may be removably connected to the second section withthe connector described previously. The second section is generallyplaced in removable fluid communication with the first section byconnecting the first connector member and the second connector member ofthe connector. The second threaded member of the second connector isreceived in the outer housing of the first connector member when thefirst connector member and second connector member are connected.

The method of delivering fluid to the patient may further includedisconnecting the second section from the first section and providing anew second section. The new second section may be connected to theexisting first section to provide removable fluid communicationtherebetween. The new second section may be connected to the samepatient or a new patient, and the injector may be actuated to deliverfluid to the patient. The present invention is additionally directed toan injection system including a source of injection fluid, a pumpdevice, and a fluid path set, summarized previously, disposed betweenthe source of injection fluid and the pump device. The first and secondsections of the fluid path set may be connected using one or more of theconnectors discussed previously.

The present invention is also an injector system that generally includesa source of injection fluid, a pump device, a fluid path set disposedbetween the source of injection fluid and the pump device, and a fluidcontrol device. The fluid path set includes a multi-position valve. Thefluid control device is operatively associated with the fluid path setand includes a valve actuator adapted to operate the multi-positionvalve. The valve actuator is adapted to close the multi-position valveto isolate the pump device from a patient and stop flow of the injectionfluid to the patient at substantially any pressure or flow rategenerated by the pump device for delivering a sharp bolus of theinjection fluid to the patient. The valve actuator may be furtheradapted to selectively place the pump device in fluid communication withthe source of injection fluid for supplying the injection fluid to thepump device.

The valve actuator may include a position indicator indicating aposition of the multi-position valve. The valve actuator may include asensor indicating presence of the multi-position valve in the valveactuator. The valve actuator may include a retainer for removablysupporting the multi-position valve.

The fluid path set may include a drip chamber and the fluid controldevice may include a fluid level sensing mechanism operativelyassociated with the drip chamber for sensing the injection fluid levelin the drip chamber. An air column detector may be operativelyassociated with the fluid path set. The pump device of the injectorsystem may be a powered injector.

A source of medical fluid may be associated with the fluid path set, anda pump operatively associated with the source of medical fluid forsupplying the medical fluid to the patient via the fluid path set. Thefluid path set may include a drip chamber and the fluid control devicemay include a fluid level sensing mechanism operatively associated withthe drip chamber for sensing the medical fluid level in the dripchamber. A shut-off valve may be associated with the pump for stoppingflow of the medical fluid to the patient. The shut-off may be anautomated pinch valve. The pump may be a peristaltic pump. The fluidcontrol device may further include guides for securing the fluid pathset in association with the pump. A hand held control device may beassociated with the pump device or the fluid control device forcontrolling the flow rate of the injection fluid from the pump device.

The injector system may further include a drip chamber having a bodywith a projection, and a fluid level sensing mechanism. The fluid levelsensing mechanism may include a drip chamber support for supporting thedrip chamber body, and a fluid level sensor associated with the dripchamber support. The drip chamber support is generally adapted tosupport the drip chamber body such that the projection is operativelyassociated with at least one fluid level sensor. The fluid level sensormay be an ultrasonic or optical fluid level sensor. The drip chambersupport may be adapted to support the drip chamber body such that theprojection is in contact with the fluid level sensor. The injectorsystem may further include an indicator light associated with the fluidlevel sensor for illuminating the drip chamber. The fluid level sensingmechanism is adapted to cause the indicator light to intermittentlyoperate if a fluid level in the drip chamber is at an unsafe level

The present invention further encompasses an air detector assembly forthe fluid control device comprising. The air detector assembly includesan air column detector adapted to detect the presence of air in medicaltubing, and a retaining device for securing the medical tubing inoperative association with the air column detector. The retaining devicegenerally includes a base adapted for association with the air columndetector, and a closure member connected to the base and adapted tosecure the medical tubing in operative association with the air columndetector.

The closure member is generally movable from a closed position whereinthe closure member secures the medical tubing in operative associationwith the air column detector, to an open position allowing the medicaltubing to be disassociated from the air column detector. The closuremember is preferably biased to the open position and secured in theclosed position by a releasable locking mechanism. The closure membermay be secured in the closed position by a releasable locking mechanism.The closure member may be formed of substantially clear plastic materialto permit viewing of the medical tubing.

The present invention is also a fluid control device for connecting apump device to a source of injection fluid. The fluid control deviceincludes a fluid path set comprising a multi-position valve adapted toassociate a patient and the source of injection fluid with the pumpdevice, and a valve actuator adapted to operate the multi-position valveto selectively isolate the pump device from the patient, and place thepump device in fluid communication with the source of injection fluidfor supplying the injection fluid to the pump device.

The present invention is a method of preparing the fluid delivery systemto deliver an injection fluid to a patient, generally includingproviding a pump device for supplying the injection fluid to the patientunder pressure, providing a fluid control device, associating a fluidpath set with the fluid control device, and connecting the pump devicewith the source of the injection fluid via the fluid path set. The pumpdevice may be a syringe actuated by a powered injector.

The step of associating the fluid path set with the fluid control devicemay include associating a multi-patient set or section with the fluidcontrol device and removably connecting a per-patient set or sectionwith the multi-patient set or section. The multi-patient set andper-patient set may be removably connected by at least one connector.The step of associating the multi-patient set with the fluid controldevice may include associating a multi-position valve associated withthe multi-patient set with a valve actuator associated with the fluidcontrol device. The pump device may be connected with the source of theinjection fluid via the multi-patient set.

The method may further include connecting the fluid path set to a sourceof medical fluid, associating the fluid path set with a pump adapted todeliver the medical fluid to the patient, and actuating the pump topurge air from the portion of the fluid path set associated with thesource of medical fluid. The method may further include connecting thefluid path set to a patient catheter.

A hand held control device may be associated with the pump device forcontrolling the pump device as part of the method.

Additionally, the method may include actuating the fluid control deviceto permit fluid communication between the pump device and the source ofinjection fluid, actuating the pump device to draw injection fluid fromthe source of injection fluid into the pump device, and actuating thepump device to purge air from the fluid path set into the source ofinjection fluid. The fluid control device and pump device may becontrolled according to instructions programmed in a control unitoperatively connected to the fluid control device and the pump device.The control device may be a graphical interface display. The first stepor act of actuating the pump device includes moving a syringe plunger ina proximal direction within the syringe to draw injection fluid into thesyringe from the source of injection fluid. The second step or act ofactuating the pump device may include reversing the direction of thesyringe plunger in the syringe to purge air from the fluid path set.

The fluid control device may be in the form of a valve actuator adaptedto actuate a multi-position valve associated with the fluid path set.The method may include deactivating the pump device and actuating thefluid control device to isolate the pump device from the source ofinjection fluid.

In another embodiment, the present invention is a method of deliveringan injection fluid to a patient, generally including providing a fluiddelivery system comprising a source of injection fluid, a pump device,and a fluid path set comprising a fluid control device disposed betweenthe source of injection fluid and the pump device; actuating the fluidcontrol device to prevent fluid communication between the pump deviceand the source of injection fluid, and to permit fluid communicationbetween the pump device and the patient; actuating the pump device todeliver pressurized injection fluid to the patient; and monitoring alevel of injection fluid in a container associated with the fluid pathset and in fluid communication with the source of injection fluid. Themethod may additionally include continuously monitoring the fluid pathset for presence of air during the delivery of the pressurized injectionfluid.

The method may further include actuating the fluid control device tostop fluid communication between the pump device and the patient atsubstantially any pressure or flow rate generated by the pump device.The pump device may be a syringe or a peristaltic pump. The step or actof actuating the pump device may include moving a syringe plunger in adistal direction within the syringe to force fluid out of the syringeand into the patient via the fluid path set. The fluid control devicemay be an automated multi-position valve. The pump device may beactuated by a hand held control device operatively connected to the pumpdevice.

The fluid control device and pump device may be controlled according toinstructions programmed in a control unit operatively connected to thefluid control device and the pump device.

The method may further include connecting the fluid path set to a sourceof medical fluid, and delivering the medical fluid to the patientassociating with a pump associated with the fluid control device.

The pump device may be a syringe and the method may further includeactuating the fluid control device to permit fluid communication betweenthe syringe and the source of injection fluid, and refilling the syringewith injection fluid from the source of injection fluid. The method mayfurther include actuating the fluid control device to close fluidcommunication between the pump device and the source of injection fluidand to permit fluid communication between the pump device and thepatient, and actuating the pump device to again deliver pressurizedinjection fluid to the patient. The method may include monitoring alevel of injection fluid in a container associated with the fluid pathset and in fluid communication with the source of injection fluid.

Furthermore, the pump device may be a syringe, and the method mayinclude actuating the fluid control device to isolate the syringe fromthe source of injection fluid and the patient, and retracting a syringeplunger in the syringe to reduce fluid pressure in the syringe.

The present invention is also directed to a fluid delivery systemcomprising a fluid path set including a first section and a secondsection adapted for removable fluid communication with the firstsection. At least one connector provides the removable fluidcommunication between the first section and the second section. Theconnector includes a first connector member defining a lumen for fluidflow through the first connector member. The first connector membercomprises a first luer member and a first annular member disposedcoaxially about the first luer member. The first luer member may berecessed within the first annular member. The connector further includesa second connector member defining a lumen for fluid through the secondconnector member. The second connector member comprises a second luermember and a second annular member disposed coaxially about the secondluer member. The second luer member may be recessed within the secondannular member. A check valve arrangement may be disposed in the lumenof one of the first and second connector members for limiting fluid flowto one direction through the medical connector. The first and secondannular members may be adapted to operably engage to securely andreleasably connect the first and second connector members. Theengagement of the first and second annular members causes engagementbetween the first and second luer members to provide fluid communicationbetween the lumens in the first and second connector members. The firstannular member may be rotatably associated with the first connectormember to rotate about the first luer member.

The first annular member may be adapted to coaxially receive the secondannular member. The first annular member may be internally threaded andthe second annular member may be externally threaded such that first andsecond annular members threadably engage to securely and releasablyconnect the first and second connector members. One of the first andsecond luer members may be formed as a male luer and the other may beformed as a female luer. The first annular member and first luer membermay define an annular cavity therebetween such that the second annularmember is at least partially received in the annular cavity when thefirst and second annular members are in operative engagement. When thesecond annular member is at least partially received in the annularcavity, the annular cavity may form a liquid-trapping chamber forinhibiting leakage of liquid between the first and second connectormembers.

The check valve arrangement comprises a stopper element disposed in thelumen in one of the first and second connector members for limitingfluid flow to one direction through the connector. The stopper elementis adapted to seat against an internal shoulder in the lumen to preventfluid flow therethrough until sufficient fluid pressure is presentwithin the lumen to unseat the stopper element from the internalshoulder. The internal shoulder may be formed by a structure inserted inthe lumen and which forms one end of a receiving cavity accommodatingthe stopper element. At least one septum may be provided in the lumen,dividing the lumen into at least two channels. The at least one septummay form the other end of the receiving cavity. Longitudinal grooves maybe defined in the wall of the receiving cavity for fluid flow throughthe cavity when sufficient fluid pressure is present within the lumen tounseat the stopper element from the internal shoulder. The insertedstructure may be a retaining sleeve and the stopper element may seatagainst the retaining sleeve until sufficient fluid pressure is presentwithin a central bore in the retaining sleeve to unseat the stopperelement from the retaining sleeve.

The stopper element may be formed of a resiliently deformable material,such that the stopper element deforms at least axially once sufficientfluid pressure is present in the lumen, thereby unseating from theinternal shoulder and permitting fluid flow through the lumen. The firstsection may be adapted for connection to a pressuring device and to asource of fluid to be loaded into the pressurizing device. The firstsection may comprise an intervening drip chamber between the fluidsource and the pressurizing device. The second section may comprise apressure isolation mechanism in accordance with the description of thepressure isolation mechanism provided previously.

Other details and advantages of the present invention will become clearwhen reading the following detailed description in conjunction with theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an embodiment of a known manual injector system.

FIG. 2 illustrates one embodiment of an injection system of the presentinvention.

FIG. 3 illustrates an embodiment of a pressure activated isolatorassembly of the present invention.

FIG. 4 illustrates an embodiment of a handheld controller or hand pieceof the present invention.

FIG. 5 illustrates another embodiment of a handheld controller of thepresent invention in which the handheld controller is connected to thefluid path via a “T” connection.

FIG. 6A illustrates another embodiment of a handheld controller of thepresent invention including a control switch for pressure feedback inlow pressure injection, a switch for high pressure injection, and aswitch for saline injection.

FIG. 6B illustrates another embodiment of a handheld controller of thepresent invention, which is wearable on a finger of the user.

FIG. 7A illustrates a schematic representation of another embodiment ofan injection system of the present invention.

FIG. 7B illustrates a side view of an embodiment of a portion of theinjection system of FIG. 7A in which a pressure transducer is in thefluid path.

FIG. 7C illustrates a side view of an embodiment of a portion of theinjection system of FIG. 7A in which a pressure transducer is separatedfrom the fluid path, by a T-connector and a length of tubing.

FIG. 7D illustrates a side cross-sectional view of an embodiment of apressure isolation valve of the present invention in which the valve isin a first, “open” state.

FIG. 7E illustrates a side cross-sectional view of the pressureisolation valve of FIG. 7D in which the valve is in a second, “closed”state.

FIG. 7F illustrates a perspective view of the pressure isolation valveof FIGS. 7D and 7E.

FIG. 7G illustrates a front view of the injection system of FIG. 7A.

FIG. 7H illustrates a front view of the handheld controller of theinjection system of FIG. 7A.

FIG. 8A illustrates an angiographic injection system of the presentinvention including a manual syringe and a pressure isolation mechanismor valve of the present invention, in which the pressure isolationmechanism is closed to isolate a pressure transducer from the fluidpath.

FIG. 8B illustrates the angiographic injection system of FIG. 8A inwhich the pressure isolation mechanism is open to place the pressuretransducer in operative communication with the fluid path.

FIG. 9A is a perspective view of a fluid delivery or injection system inaccordance with another embodiment of and including generally analogouscomponents to the system of FIG. 7G.

FIG. 9B is a perspective view of another embodiment of the fluiddelivery or injection system including priming bulbs as part of thefluid path.

FIG. 10A is a side and partially perspective view of a fluid path setused with the fluid delivery system of FIG. 9A.

FIG. 10B is a side and partially perspective view of a fluid path setused with the fluid delivery system of FIG. 9B.

FIG. 11A is a perspective view of a drip chamber in accordance with thepresent invention and adapted for use in the fluid path of FIG. 10A.

FIG. 11B is a perspective view of another embodiment of the drip chamberadapted for use in the fluid path set of FIG. 10A.

FIG. 12 is a perspective view of another embodiment of the pressureisolation mechanism or valve of the present invention and provided inthe fluid path set of FIG. 10A.

FIG. 13 is a cross section view taken along lines 13-13 in FIG. 12.

FIG. 14 is an exploded perspective view of the pressure isolationmechanism of FIG. 12.

FIG. 15 is a perspective view of a biasing valve member used in thepressure isolation mechanism of FIG. 12.

FIG. 16 is a perspective view of a connector in accordance with thepresent invention and adapted for use in the fluid path set of FIG. 10A,and showing first and second connector members of the connectordisconnected from one another.

FIG. 17 is a longitudinal cross sectional view of the connector of FIG.16, showing the first and second connector members connected together.

FIG. 18 is a longitudinal cross sectional view of the first connectormember of the connector of FIGS. 16 and 17.

FIG. 19 is a longitudinal cross sectional view of the second connectormember of the connector of FIGS. 16 and 17.

FIG. 20 is a perspective view of a fluid control module or device inaccordance with the present invention.

FIG. 21 is a second perspective view of the fluid control module ordevice shown in FIG. 20.

FIG. 22 is a longitudinal cross sectional view of a valve actuator ofthe fluid control module or device shown in FIGS. 20 and 21.

FIG. 23 is an exploded perspective view of the valve actuator of FIG.22;

FIG. 24A is a perspective view of a fluid level sensing mechanism of thefluid control module or device shown in FIGS. 20 and 21 and adapted tointerface with the drip chamber shown in FIG. 11A.

FIG. 24B is a perspective view of the fluid level sensing mechanismadapted to interface with the drip chamber shown in FIG. 11B.

FIG. 25A is an exploded perspective view of the fluid level sensingmechanism of FIG. 24A.

FIG. 25B is an exploded perspective view of the fluid level sensingmechanism of FIG. 24B.

FIG. 26A is a transverse cross sectional view of the fluid level sensingmechanism of FIG. 24A.

FIG. 26B is a transverse cross sectional view of the fluid level sensingmechanism of FIG. 24B.

FIG. 27 is an exploded perspective view of a peristaltic pump of thefluid control module or device shown in FIGS. 20 and 21.

FIG. 28 is an exploded perspective view of a pinch valve assembly of thefluid control module or device shown in FIGS. 20 and 21.

FIG. 29 is a perspective view of an air detector assembly of the fluidcontrol module or device shown in FIGS. 20 and 21.

FIG. 30 is a longitudinal cross sectional view of the air detectorassembly of FIG. 29.

FIG. 31 is an exploded perspective view of the air detector assembly ofFIGS. 29 and 30.

FIG. 32 is an elevational view of the fluid delivery or injection systemof FIG. 9 associated with a hospital examination table.

FIG. 33 is a top perspective view of the fluid delivery or injectionsystem of FIG. 32.

FIGS. 34-36 are respective graphical user interface displays of a setupwizard control system used to control the fluid delivery or injectionsystem of the present invention,

FIG. 37 is an exploded perspective view of an embodiment of the firstconnector member for an alternative connector used in the fluid path setof FIGS. 10A-10B, showing the first connector member incorporating acheck valve arrangement in accordance with the present invention.

FIG. 38 is a longitudinal cross sectional view of the first connectormember of FIG. 37.

FIG. 39A is a longitudinal cross sectional view of another embodiment ofthe second connector member for the alternative connector used in thefluid path set of FIG. 10;

FIG. 39B is a cross sectional view showing the second connector memberof FIG. 39A with a flow interrupter.

FIG. 40A is a longitudinal cross sectional view showing the first andsecond connector members of FIGS. 38 and 39A connected together andforming the alternative embodiment of the connector for use in the fluidpath set of FIGS. 10A-10B.

FIG. 40B is a longitudinal cross sectional view showing the first andsecond connector members of FIGS. 38 and 39B connected together and thecheck valve arrangement omitted from the first connector member.

FIG. 41 is a longitudinal cross sectional view of the first connectormember of FIG. 37 in the form of a swivel-type first connector member.

FIG. 42 is an exploded perspective view of the swiveling first connectormember of FIG. 41.

FIG. 43 is a cross sectional view take along line 43-43 in FIG. 38.

FIG. 44 is a longitudinal cross sectional view of the first connectormember of FIG. 38 having the check valve arrangement removed.

FIG. 45 is a longitudinal cross sectional view showing the first andsecond connector members connected as depicted in FIG. 40A and showingthe results of fluid pressure acting on the check valve arrangement.

FIG. 46 is a cross sectional view take along line 46-46 in FIG. 45.

FIG. 47 is a longitudinal cross sectional view showing the first andsecond connector members connected as depicted in FIG. 40 and showingalternative variations of the first and second connector members inaccordance with the present invention.

FIG. 48 is a perspective view of another embodiment of the pressureisolation mechanism including a valve arrangement adapted to providehemodynamic pressure dampening correction.

FIG. 49 is a partial cross sectional view of the pressure isolationmechanism of FIG. 48 illustrating the valve arrangement.

FIGS. 50A-50C are perspective views of respective embodiments of anelastomeric disk valve associated with the valve arrangement of FIG. 49.

FIG. 51 is a perspective view of a sleeve adaptor used to associate theelastomeric disk valve with the pressure isolation mechanism.

FIG. 52 is perspective view of a distal end of the sleeve adaptor ofFIG. 51.

FIG. 53 is a cross sectional view of a first alternative embodiment ofthe valve arrangement shown in FIG. 49.

FIG. 54 is a cross sectional view of a second alternative embodiment ofthe valve arrangement shown in FIG. 49.

FIG. 55 is a cross sectional view of a third alternative embodiment ofthe valve arrangement shown in FIG. 49.

FIG. 56 is a cross-sectional view of a fourth alternative embodiment ofthe valve arrangement shown in FIG. 49.

FIG. 57 is a cross-sectional view of a fifth alternative embodiment ofthe valve arrangement shown in FIG. 49.

DETAILED DESCRIPTION OF THE INVENTION

In one aspect, the present invention provides an energy/signal source togenerate fluid pressure/flow while also providing to the user tactileand/or audible feedback of the fluid pressure generated, allowing theuser to modulate the fluid pressure/flow. The powered injection systemof the present invention is capable of providing, for example, bothprecise low-flow/low-pressure fluid delivery for powered coronaryinjections and high-flow/high-pressure fluid delivery for ventricleinjections.

FIG. 2 illustrates one embodiment of the present invention in whichinjector system 10 is preferably divided into two sections: amulti-patient section or set A and a per-patient disposable section orset B. Section or set A and section or set B are preferably separatedand removably coupled into fluid connection by a high-pressure connectoror by a high-pressure, “aseptic” connector 20 such as the septumconnector disclosed in U.S. Pat. No. 6,096,011, assigned to the assigneeof the present invention, the disclosure of which is incorporated hereinby reference. The aseptic coupler or connector of U.S. Pat. No.6,096,011 is suitable for repeated use (coupling and uncoupling) atrelatively high pressures. Aseptic connector 20 preferably maintains aleak-proof seal at high pressures after many such uses and can, forexample, include a surface that can be disinfected (for example, betweenpatients) by wiping with a suitable disinfectant. Another high-pressureaseptic connector suitable for use in the present invention is disclosedin U.S. patent application Ser. No. 09/553,822, filed on Apr. 21, 2000,assigned to the assignee of the present invention, the disclosure ofwhich is incorporated herein by reference.

Multi-patient set A preferably includes a powered injector 30 which istypically an electromechanical drive system for generating fluidpressure/flow via, for example, a pressurizing chamber such as a syringe40 as known in the art. Suitable powered injectors and syringes for usein the present invention are disclosed, for example, in PCT PublicationNo. WO 97/07841 and U.S. Pat. No. 4,677,980, assigned to the assignee ofthe present invention, the disclosures of which are incorporated hereinby reference.

In general, the injector drive is an electromechanical device thatcreates linear motion acting on a syringe plunger (not shown in FIG. 2)to provide the generation of fluid pressure/flow. A source of injectionmedia 60, for example, a contrast bottle, is in fluid connection withthe syringe via, for example, an electromechanical valve actuatorassembly 50 for controlling and directing fluid flow by acting uponpreferably disposable valves 52 and 54. Valves 52 and 54 are preferablymulti-position valves that are fluid wetted. Valves 52 and 54 canalternatively or additionally be manually operated. Contrast bottle orcontainer 60 can be prepackaged contrast media, often distributed in aglass or plastic container with a rubber septum for allowing connectionsvia IV spikes. An interim container or reservoir 70 is preferably placedbetween contrast bottle 60 and electromechanical valve assembly 50 toprovide an air gap in the fluid path to enable purging of air from thesystem and to allow level detection of contrast source 60 which helps toprevent reintroduction of air once purged. Interim reservoir 70 canoperate in conjunction with a contrast level detection system asdescribed in further detail below. A contrast level detector 80 can, forexample, include one or more electrical, optical, ultrasound, ormechanical sensors that detect the presence of fluid at a certain levelin interim reservoir 70.

Further protection against injection of air into a patient can beprovided by variety of mechanisms for detection of air in the fluid pathor stream. For example, ultrasonic bubble detection can be used todetect the presence of air in the fluid path. Likewise, backlighting canfacilitate air bubble detection by the operator. In the backlightingmethod of bubble detection, the injector side of the fluid path isilluminated to increase visualization of the fluid path, fluid presenceand air presence.

At least one source 90 of another fluid, typically saline or othersuitable medium, can also be provided. Additional fluid sources, such astherapeutic fluids, can also be provided. Additional fluid sources suchas saline supply 90 are preferably in operative or fluid connection witha pressurizing mechanism such as a powered injector or a peristalticpump 100. In FIG. 2, peristaltic pump 100 in operative connection withthe saline source 90 is in fluid connection with the fluid path ofinjector 30 via electromechanical valve actuator assembly 50.

A controller unit 200 provides power to injector 30 and to peristalticpump 100 in a controlled manner. Controller unit 200 providescommunication between the various system components. A graphical userinterface display 210 is preferably provided in connection withcontroller unit 200 to display information to the user and to enable theuser to set and adjust device parameters. An audible feedback source 220can be provided, for example, to provide feedback to the user of therate of flow provided by injector 30. For example, a sound can increasein pitch, volume and/or frequency as flow rate is increased.

Per-patient disposable set B includes fluid wetted components of thefluid delivery path. Per-patient disposable set B preferably includes awaste port 310, for example through which patient blood can be drawn, apressure measurement port 320, and an interface 330 to a catheter 340,for example, a connector such as a standard luer connector. Waste port310 can, for example, include a manually activated or automated valve toallow discharge of unwanted fluid and connection of, for example,manually operated syringes. Moreover, a powered aspiration mechanism,for example a peristaltic pump 314 connected via tubing to a waste bag316, can be connected to waste port 310 via, for example, a standardconnector 312, to aspirate fluid from the system as well as to drawblood from the patient. Drawing fluid from the system and blood from thepatient into a waste bag 316 assists in eliminating air from the fluiddelivery system.

Pressure port 320 preferably includes a pressure-activated isolator 350for pressure transducer isolation as, for example, illustrated in FIG.3. Pressure-activated isolator 350 is a fluid activated assembly that islocated in line with the injection flow. In the embodiment of FIG. 3, avalve 352 within the assembly isolates pressure transducer 360 byshutting off during high-pressure injections. A biasing member ormechanism such as a spring 354 returns valve 352 to its original openposition when the injector system is not injecting at high pressure,thus opening the fluid path to pressure transducer 360. In theembodiment of FIGS. 2 and 3, pressure-activated isolator 350 transitionsto a closed position to isolate only pressure transducer 360, which isnot in fluid connection with contrast source 60 or saline source 90other than through pressure-activated isolator 350. Pressure transducer360 can, for example, be located near the patient to substantiallyreduce or remove pressure signal dampening resulting from interveningtubing, fluid and system components and thereby improve accuracy ascompared to other pressure measurement systems currently used inangiographic procedures. Preferably, pressure transducer 360 isseparated by a minimum, for example by no more than approximately threefeet, of tubing from the patient/catheter connector. Because of themulti-patient nature of set A, the pressure transducer assembly and theremainder of per-patient disposable set B are preferably locateddownstream of a double check valve 370 to provide continuousmeasurements. As such, a pressure isolation mechanism such as describedabove is required to isolate pressure transducer 360 from high pressureduring power injection.

The system also includes a manually operated, for example, a handheld orhand operated, control 400 that can, for example, generate or process acontrol signal that is electrical, mechanical, pneumatic, optical, radiofrequency, audible or any combination thereof to effect control ofinjector 30 and preferably to also effect control of peristaltic pump100. Handheld control 400 also preferably provides feedback, forexample, tactile, visual, audible, etc., of the injected fluid pressureand flow to the operator. Handheld control 400 preferably provides atleast one type of feedback, for example, tactile feedback. In theembodiments of FIGS. 2, 4 and 5, the handheld control or hand piece isin operative communication with the fluid flow and allows the user tofeel the pressure in the fluid path line. Preferably, an electricalswitch allows the user to turn on/off and modulate the fluid/flowpressure of the system for low-pressure/low-flow coronary injectionsonly. High-pressure injection is activated, for example, using eitherdisplay 210 or a separate, second control on the handheld control. Thehandheld control thus provides pressure feedback to the user whilecontrolling the low-pressure/low-flow coronary injections.

The handheld controls of the present invention can, for example, includea fluid path containment chamber in which a movable element is able totravel a pre-determined distance. The moveable element is preferably indirect contact with the fluid path and is affected by fluid flow andpressure. The movable element incorporates a mechanism to process asignal, which can be used to control the fluid pressure/flow sourceremotely. The handheld device is capable of being used with a signalprocessor related to the movement of the moveable element as known inthe art.

In one embodiment of the present invention, a handheld control device500 incorporates a moveable piston 510 slidably disposed within achamber 520 in a direction generally perpendicular to the direction offluid flow as illustrated in FIG. 4. Chamber 520 and piston 510 can bedirectly in the fluid path or can be spaced from the fluid path by alength of tubing (see, for example, FIG. 5). Handheld device 500 allowsmoveable piston 510 to be positioned under one finger while device 500is held in the hand. Piston 510 preferably incorporates a switch 530,that when compressed, controls the fluid flow generated by an externalfluid pressure/flow source, for example, injector 30. Upon generation ofthe pressure, piston 510 is displaced by increased pressure, which isdetectable by the operator. Further compression of piston 510 by theoperator preferably increases the signal to the fluid flow/pressuregenerator, resulting in an increase in the pressure/flow and anincreased pressure on piston 510, which is felt by the operator.Backpressure or tubing occlusion causes increased pressure in thesystem, upward movement of piston 510 and tactile feedback to theoperator, thereby alerting the operator to potential problems in theinjection procedure. The system can also provide audible and/or visualfeedback of the flow rate via, for example, user display 210 that ispreferably controlled by the position of piston 510.

As illustrated in FIG. 5, a handheld control 500′ can be connected in a“T” 550′ off of the main line for more flexibility. A purge valve 540′can be located at the end of handheld control 500′ for air eliminationduring system purge. Air can also be purged from the handheld control500′ before it is connected to the fluid path. FIG. 5 also illustrates asecond switch 560′ for initiation of a high pressure injection. Anadditional switch or switches can also be provided to, for example,control delivery of saline.

FIGS. 6A and 6B illustrate other, ergonomic handheld controls. Handheldcontrol 600 of FIG. 6A includes a chamber 620 that can be in fluidconnection with the injection system fluid path as described above. Alow pressure control switch 610 similar in operation to piston 510 isslidably disposed within chamber 620 to control low-pressure injectionsof contrast. Chamber 620 can, for example, be formed to conform to thehand of the user. A switch 630 to begin a high pressure injection viainjector 30 is provided on handheld control 600. Also, a switch 640 tocontrol delivery of saline is provided on handheld control 600.

FIG. 6B illustrates an embodiment of a finger-wearable handheld control700. In that regard, a finger of the user's hand passes through passage710 in control 700 while control 700 is held in the user's hand Arotating switch 720 controls low-pressure injection. A high pressureinjection switch 730 and a saline switch 740 are also provided.

System 10 (FIG. 2) can also include a manually operated foot controller420 including one or more actuators 430 in communication with controller200. Foot controller 420 can, for example, be used to control flowthrough system 10 in conjunction with or independently of handheldcontroller 400.

Another embodiment of an injector system 800 is illustrated in FIGS. 7Athrough 7H. In this embodiment, referring primarily to FIGS. 7A and 7G,a fluid control module 810 is in operative connection with a poweredinjector 830 to which a syringe 840 is connected as described above.Syringe 840 is in fluid connection with an automated valve 852 of fluidcontrol module 810, which is also in fluid connection with a source ofcontrast 860 via an intermediate drip chamber 870 (see FIG. 7A). Dripchamber 870 preferably includes a fluid level sensing mechanism 880. Apreferably automated valve/stopcock 852 such as known in the art is alsoin fluid connection with a first, inlet port of a lumen 954 of apressure isolation valve 950 (see, for example, FIGS. 7D through 7F).Valve 852 prevents saline and/or contaminated fluids from enteringsyringe 840 and enables the operator to stop flow of injection fluid(for example, contrast) from syringe 840 quickly at any pressure or flowrate. This ability to substantially immediately stop flow of injectionfluid at any pressure and flow rate substantially removes the effects ofsystem compliance and enables delivery of a “sharp” bolus. An air columndetector 856 can be placed in line between stopcock 852 and pressureisolation valve 950.

Fluid control module 810 further includes a source of saline 890 influid connection with a peristaltic pump 900 via an intervening dripchamber 910. Drip chamber 910 preferably includes a fluid level sensingmechanism 920. Peristaltic pump 900 is in fluid connection with apreferably automated valve/stopcock 854, which is in fluid connectionwith pressure isolation valve 950. In addition to controlling flow ofsaline, valve 854 prevents contaminated fluids from reaching peristalticpump 900 and saline source 890. An air column detector 858 can be placedin line between stopcock 854 and pressure isolation valve 950.

A controller 970 and a display 974 (see FIG. 7A) are also in operativeconnection with injector 830 as described above. Furthermore, handheldcontroller 1000 is in operative connection with injector 830 and therebywith fluid control module 810. In the embodiment of FIGS. 7A through 7Cand FIG. 7G, handheld controller 1000 does not provide tactile feedbackof system pressure to the operator. However, a handheld controllerproviding such tactile feedback (for example, handheld controller 600)can readily be used in connection with system 800. Moreover, a footcontroller as described above can also be provided.

In general, the preferably per-patient disposable portion or set ofsystem 800 is illustrated within dashed lines in FIGS. 7A, 7B, and 7C.Two connectors 990 a and 990 b (which are preferably aseptic connectorsas described above) are used to connect the multi-patient fluid path setwith the per-patient fluid path set. Use of two separate/parallel fluidlines and two separate connectors to connect the multi-patient set withthe per-patient disposable set affords a number of benefits over currentangiographic injection systems including decreased contrast waste andavoidance of injecting potentially hazardous amounts of contrast intothe patient during saline purges. Moreover, system 800 facilitates closeplacement of pressure transducer 980 to the patient, improvingmeasurement accuracy as compared to currently available systems.Although handheld controller 1000 in the embodiments of FIGS. 7A through7H is not in direct connection with the fluid path, it is preferablydisposable because of contamination with bodily fluids that typicallyoccurs from operator handling thereof.

Lumen 954, via a second, outlet port thereof, of pressure isolationvalve 950 is preferably in fluid connection with an automated or manualvalve/stopcock 994, which preferably includes a waste port 996 asdescribed above. Catheter 1100 is preferably connected via a rotatingluer connection 998.

FIG. 7B illustrates a portion of a fluid path set for use in system 800of FIG. 7A in which a pressure transducer 980 is directly in the salinefluid path. FIG. 7C illustrates a fluid path set for use in system 800of FIG. 7A in which pressure transducer 980 is separated from the salinefluid path by a “T” connector 982 and a length of tubing 984. In theembodiments of FIGS. 7B and 7C, spikes 976 a and 976 b are used toconnect to contrast source 860 and saline source 890, respectively. Ingeneral, standard luer connections are used to connect most of thecomponents of system 800. In FIGS. 7B and 7C several of these luerconnections are illustrated in a disconnected state. Alternatively, oneor more of the illustrated connections can, for example, be non-luer orbonded connections.

One embodiment of a pressure isolation valve 950 is illustrated in FIGS.7D through 7F. Pressure isolation valve 950 includes a housing 952 witha high pressure lumen 954, through which fluid passes under pressure.Pressure isolation valve 950 also includes a port 956 to which pressuretransducer 980 and saline source 890 are connected. A piston 958 acts toisolate pressure transducer 980 once a given pressure is reached inlumen 954 of pressure isolation valve 950. In an “open” or rest state,as shown in FIG. 7D, there is hydraulic or fluid communication betweenlumen 954, including catheter 1100 and injector 840 connected thereto,and isolation port 956, including pressure transducer 980 and the salinefluid path connected thereto.

Preferably, the clearances and apertures within pressure isolation valve950 are sufficiently generous to transmit changes in pressure thatnormally occur during normal heart function quickly, as to not damp orattenuate the signal. The pressure effect on piston 958 of the flow ofinjection fluid from syringe 840 through lumen 954 is illustrated withdashed arrows in FIG. 7D while the flow of saline through pressureisolation mechanism 950 is illustrated with solid arrows. When thepressure within lumen 954 increases during an injection, piston 958responds by moving to the right in the orientation of FIGS. 7D and 7E,compressing a spring 960 until a seal portion 962 at the left end ofpiston 958 contacts a sealing seat 964 as illustrated in FIG. 7E. Atthis point, lumen or port 956 is isolated from lumen 954 and anyadditional increase in pressure acts to increase or improve theeffectiveness of the seal 962. When the pressure within lumen 954subsides, spring 960 reopens pressure isolation valve 950 by pushingpiston 958 to the left. In one embodiment, fluid does not flow throughport 956. In this embodiment, pressure isolation valve 950 only isolatesthe tubing and devices distal to port 956 from high pressure and doesnot control flow.

Pressure isolation valve 950 of the present invention is suited for usein any medical fluid path in which it is desirable to automaticallyisolate a pressure sensitive fluid path component, for example, apressure transducer or other fluid path component or fluid pathway frompressures above a certain predetermined pressure. The pressure at whichpressure isolation valve 950 isolates port 956 from lumen 954 can bereadily and easily adjusted through variation of a number of variablesas known to those skilled in the art, including, for example, variousvalve dimensions and the properties of spring 960, for example, theforce constant thereof. Connection of pressure isolation valve 950 intoany fluid path is quite simple. In that regard, lumen 954 is simplyplaced in the fluid path via connection of ports 954 a and 954 b todisconnected or open ends of the fluid path without any other change tothe fluid path or to pressure isolation valve 950. Standard connectionssuch as luer connections as known in the medical arts can be used toconnect lumen 954 to the fluid path. Valve 950 can also be incorporatedinto or embedded within other devices such as a manifold, a pressuretransducer or a connector.

In an alternative to mechanical operation of valve piston 958 asdescribed above, valve piston 958 can also be controlled via anelectromechanical mechanism. For example, a pressure sensor such aspressure sensor or transducer 980 (see, for example, FIG. 7B) can send asignal to an actuator, for example, in the operative position of andfunctioning in a similar manner to spring 960 as known in the controlart to control the position of valve piston 958 and thereby controlfluid flow through port 956.

FIGS. 8A and 8B illustrate use of pressure isolation valve 950 toautomatically isolate a pressure transducer P from increased pressuresin a manual injection system such as set forth in FIG. 1. Valve V³, usedfor manual isolation of a pressure transducer as described previously,can be removed from the fluid path or retained therein. As illustratedin FIG. 8A, application of a force F to the syringe plunger extensioncauses pressurized fluid to flow from the syringe into the fluid path.The elevated pressure causes pressure within lumen 954 to increase. Asdiscussed previously in connection with FIGS. 7D and 7E, piston 958responds by moving to the right in the orientation of FIGS. 8A and 8B,compressing spring 960 until seal portion 962 contacts sealing seat 964as illustrated in FIG. 8A. At this point, port 956 and pressuretransducer P are isolated from lumen 954 and the remainder of the fluidpath. As illustrated in FIG. 8B, when the syringe in inactivated, thepressure within lumen 954 subsides, and spring 960 reopens pressureisolation valve 950 by pushing piston 958 to the left.

Incorporation of pressure isolation valve 950 into the fluid path ofFIGS. 8A and 8B provides a substantial improvement compared to theinjection system of FIG. 1. For example, it is taxing and difficult fora physician or other operator using the system of FIG. 1 to operate eachof valves V¹, V² and V³. Operators often either forget to close valve V³during injections, thereby resulting in damaged pressure transducers orfail to reopen the valves post-injection preventing proper or timelypatient monitoring. Injection procedures are greatly facilitated in thesystem of FIGS. 8A and 8B by automation of the isolation of pressuretransducer P at elevated pressures.

As discussed above, saline is used occasionally during routinecatheterization procedures. For example, controls 1020 a or 1020 b onhandheld control 1000 can send a signal to control the flow of saline.For patient safety, it is desirable to introduce the saline close to theproximal end of catheter 1000 so the amount of contrast purged ahead ofthe saline is minimized during a saline injection. Once again, theparallel line configuration of the contrast delivery and saline deliverfluid paths of present invention assist in preventing such undesirableinjections.

Since the required saline flow rates are low and the viscosity of salineis much lower than the viscosity of contrast, the pressures required toforce saline through catheter 1100 are much less than that of contrast.By protecting the saline line from the high pressures required forcontrast injection, additional system compliance is avoided and thesaline line does not need to be made of the same high-pressure line asthe contrast. Protection of the saline line from high pressure isaccomplished by connecting the saline line to port 956 of pressureisolation valve 950 to introduce the saline flow as illustrated withsolid arrows in FIG. 7D. In this embodiment, port 956 is normally open,permitting the flow of saline therethrough, when required, as well asthe monitoring of the patient blood pressure. During a high-pressureinjection, pressure isolation valve 950 functions as described above andprotects pressure transducer 980 and the low-pressure saline line fromthe high contrast injection pressures.

The elevation of catheter 1100 often changes during the course of aninjection procedure, for example, as the patient is raised or lowered.Such changes in elevation of catheter 1100 can result in erroneous bloodpressure readings by pressure transducer 980. Therefore, pressuretransducer 980 is preferably positioned such that it changes elevationwith catheter 1100 and is not dependent upon the position of theinjection system, including the position of injector 830.

In one embodiment illustrated in FIGS. 7G and 7H, handheld controller1000 included a plunger or stern control 1010 that, when in a first/lowpressure mode, is depressed by the operator to control the flow ofcontrast from syringe 840. The farther plunger 1010 is depressed, thegreater the flow rate via, for example, a potentiometer such as a linearpotentiometer within housing 1020 of controller 1000. In thisembodiment, the operator can use graphical user interface display 974 tochange the mode of plunger 1010 to a second mode in which it causesinjector 830 to initiate a high pressure injection as preprogrammed bythe operator. In this second/high pressure mode, the operator maintainsplunger 1010 in a depressed state to continue the injection. Preferably,if plunger 1010 is released, the high-pressure injection is terminatedsubstantially immediately, for example, by control of valve 852.Handheld controller 1000 also includes at least one switch to controlsaline flow in system 800. In the embodiment of FIG. 7H, handheldcontroller 1000 includes two saline switches 1030 a and 1030 b on eitherside of plunger 1010 for ease of access by the operator. In thisembodiment, switches 1030 a and 1030 b include resilient cantileveredmembers 1032 a and 1032 b, respectively, which are depressed by theoperator to deliver saline through system 800. Preferably, one ofswitches 1030 a or 1030 b must be maintained in a depressed state by theoperator to continue delivery of saline. If the depressed switch isreleased, saline flow is preferably stopped substantially immediately,for example, via control of valve 854.

As illustrated in FIG. 7G, many of the components of system 800 can besupported on a mobile stand 805. Injector 830 is preferably rotatableabout stand 805 as indicated by the arrow of FIG. 7G. In one embodimentof system 800 of FIGS. 7G and 7H: stopcocks were obtained from MedicalAssociates Network, Inc., a distributor for Elcam Plastic, under productnumber 565302; spikes were obtained from Qosina under product numbers23202 and 23207, tubing was obtained from Merit Medical under productnumbers DCT-100 and DCT-148; connectors were obtained from Merit Medicalunder product number 102101003, a rotating hub was obtained from MedicalAssociates Network, Inc., a distributor for Elcam Plastic, under productnumber 565310; a peristaltic pump from Watson-Marlow was obtained havinga product number of 133.4451.THF; and fluid level sensor from Omron wereobtained under product number EESPX613.

The following describes a typical use scenario of injection systems ofthe present invention and assumes that all fluid path components areassembled/connected and located in their proper position, includingcontrast and saline containers.

Typically, the first step in an injection procedure is replacing air inthe fluid path with fluid. By operator initiation and machine control,the powered injector causes the syringe plunger to move rearward towardthe powered injector, thereby creating a negative pressure at theconnection point to a control valve in proximity to the contrast interimcontainer. The control valve is positioned to allow fluid flow from thecontrast bottle, into the interim container and into the syringe. Upondrawing a predetermined amount of contrast into the syringe, theinjector drive preferably reverses direction creating a positivepressure and fluid movement in the direction of the contrast containeror the catheter, which is not connected to a patient, to drive anyentrapped air out of the fluid path into an “air gap” established in theinterim container or through the catheter. Air is further preferablyinitially purged from the system during start-up by, for example,distributing a fluid such as saline through the fluid path, sometimesreferred to as “priming”. The system is preferably maintained air-freeduring an injection procedure. Priming is preferably done once perpatient or once per multi-patient, depending on disposable fluid pathconfiguration.

The system can include, for example, “contrast low” level (need forrefill) and “stop filling” limit sensors on the interim reservoir asdescribed above to help ensure that air is not aspirated into thecontrast syringe during a fill cycle. An ultrasonic air column sensor orsensors and/or other types of sensors can also be included downstream ofthe injector to detect air gaps within the line as a secondary safetysensor.

By operator initiation and machine control, a second fluid pumpconnected to a bulk source of saline, typically a prefilled bag,provides fluid flow in the direction of patient catheter. Enough salineis preferably pumped throughout disposable set to achieve elimination ofall visible air during priming. Using the saline priming feature, ahandheld controller that is in fluid connection with the fluid path toprovide tactile feedback as described previously can, for example, bepurged of air by opening an integral bleed valve. After priming iscomplete the bleed valve is closed.

Once the system is properly set up and primed, it can be connected tothe patient via the catheter. The system preferably has a range ofparameters for flow, pressure, variable flow, alarms and performancelimits as known in the art.

To deliver contrast at low flow and low pressure, for example, to thecoronary arteries, depressing a first button, piston or other controlleron the handheld controller initiates flow of contrast and in someembodiments provides feedback, for example, tactile and/or audiblefeedback. Further depressing the button on the hand controllerpreferably increases the flow rate of contrast. If at any time thebutton is released, the fluid flow preferably stops and any feedbackends. This “dead-man” operability can be provided, for example, bybiasing, for example spring loading, the first control or actuatortoward the off position. The minimum and maximum flow are preferablyestablished by the parameters set using a graphical user interface onthe display.

To deliver contrast at high flow and high pressure, for example, to theleft ventricle, a separate switch or second actuator/controller on thehand control is preferably depressed. Alternatively, a second mode ofthe first actuator/controller can be entered to control high pressureflow. In embodiments in which the handheld control provides tactilefeedback during low-pressure injection, preferably no such tactilefeedback is provided during high pressure flow. However, other feedbacksuch as an audible tone feedback different than any audible toneprovided during the low-pressure mode can be provided. Thehigh-pressure/high-flow function is preferably first input/selected fromthe parameters input/set using the graphical user interface on thedisplay. The high-flow and high-pressure injection is preferablypreprogrammed and the flow cannot be varied. As discussed above, anydirect, tactile feedback is preferably eliminated, as the pressure isoften over 1000 psi. If at any time the second button is released, theinjection preferably stops.

To deliver saline, a second or third switch, controller or actuator onthe hand controller is preferably selected, causing saline flow at apre-selected flow rate. Alternatively, a single controller or actuatorhaving three different control modes can be used. As with the otheractuators or actuator modes on the handheld controller, if at any timethe third button is released, the saline flow preferably stops.

A pressure sensor is preferably connected to a pressure isolation valveas described above. Patient pressure monitoring can be determined at anytime except when an injection of fluid exceeds the pressure set by thepressure isolation valve.

A multi-patient set can be designed so that at least some portionsthereof can safely be reused for multiple patients. In such a design,for example, the syringe and interface to contrast/saline components,disposable valves and related tubing, and a multi-use high-pressure,aseptic connector can preferably be reused for multiple patients.

Handheld controllers, whether or not in fluid connection with the fluidpath, and related tubing and check valves are preferably replaced foreach patient. Likewise, any waste port, pressure port, and the interfaceto catheter are preferably replaced for each patient. Aseptic connectorsof a multi-patient set can, for example, be wiped clean beforeconnecting a disposable set for each new patient. Reusable ormulti-patient sets preferably have a limited numbers of reuses andpreferably are not used for longer than a set period of time, forexample, an 8-hour period.

Another embodiment of a fluid injector or delivery system 1200 isillustrated generally in FIGS. 9A-9B. In this embodiment, an injector1300 is operatively associated with a fluid control module 1400. Thedetails of the injector 1300 are set forth in U.S. Pat. Nos. 7,549,977and 7,563,249, which are each incorporated herein by reference in theirentirety. The injector 1300 is adapted to support and actuate a syringe,as described in the foregoing applications. The fluid control module1400 is associated with the injector 1300 for controlling fluid flowsdelivered by the injector 1300. The fluid control module 1400 isgenerally adapted to support and control a fluid path set 1700 used toconnect a syringe associated with the injector 1300 to a catheter (notshown) to be associated with a patient.

The fluid delivery system 1200 further includes a support assembly 1600adapted to support the injector 1300 and the fluid control module 1400,as discussed further herein. The support assembly 1600 may be configuredas a movable platform or base so that the fluid delivery system 1200 isgenerally transportable, or for connection to a standard hospital bed orexamination table on which a patient will be located during an injectionprocedure. Additionally, the fluid delivery system 1200 preferablyfurther includes a user-input control section or device 1800 forinterfacing with computer hardware/software (i.e., electronic memory) ofthe fluid control module 1400 and/or the injector 1300. While thedetails of the fluid control module 1400 are set forth in detailhereinafter, the fluid control module 1400 generally includes a housing1402, a valve actuator 1404 for controlling a fluid control valve, afluid level sensing mechanism 1406, a peristaltic pump 1408, anautomatic shut-off or pinch valve 1410, and an air detector assembly1412. The details of the control section 1800 are also set forthhereinafter in this disclosure.

As indicated, the fluid control module 1400 is generally adapted tosupport and control the fluid path set 1700 used to connect a syringeassociated with the injector 1300 to a catheter (not shown). Referringnow to FIGS. 9A-9B and 10A-10B, the fluid path set 1700 is shown ingreater detail in FIGS. 10A-10B. The fluid path set 1700 may beconsidered to include a syringe 1702 that is to be associated with theinjector 1300. The fluid path set 1700 is generally used to associatethe syringe 1702 with a first or primary source of injection fluid 1704,also referred to herein as a primary fluid container, which will beloaded into the syringe 1702 for an injection procedure. The primaryfluid container 1704 may be contrast media in the case of anangiographic procedure, as an example. The fluid path set 1700 isfurther adapted to associate the fluid control module 1400 with asecondary or additional source of fluid 1706, also referred to herein asa secondary fluid container, to be supplied or delivered to the patientvia the catheter. In a typical angiographic procedure, saline is used asa secondary flushing fluid which is supplied to the patient betweeninjections of contrast media.

In a general injection procedure involving the fluid delivery system.1200, the injector 1300 is filled with fluid from the primary fluidcontainer 1704 and delivers the fluid via the fluid path set 1700 to thecatheter and, ultimately, the patient. The fluid control module 1400generally controls or manages the delivery of the injection through avalve associated with the fluid path set 1700, which is controlled oractuated by the valve actuator 1404 on the fluid control module 1400.The fluid control module 1400 is further adapted to deliver the fluidfrom the secondary fluid container 1706 under pressure via theperistaltic pump 1408 on the fluid control module 1400.

The fluid path set 1700, as illustrated in FIGS. 10A-10B, generallycomprises a first section or set 1710 and a second section or set 1720.The first section 1710 is generally adapted to connect the syringe 1702to the primary fluid container 1704, and to connect the second section1720 to the secondary fluid container 1706. The first section 1710 ispreferably multi-patient section or set disposed after a preset numberof injection procedures are accomplished with the fluid delivery system1200. Thus, the first section 1710 may be used for a preset number ofinjection procedures involving one or more with patients and may then bediscarded. Optionally, the first section 1710 may be adapted to bere-sterilized for reuse. The first section 1710 is preferably providedas a sterile set, preferably in a sterile package. The second section1720 is a per-patient section or set, which is preferably disposed ofafter each injection procedure involving the fluid delivery system 1200.The fluid path set 1700 is generally similar to the fluid path setillustrated in FIG. 7B, discussed previously, but includes thestructures discussed hereinafter. The first section 1710 and secondsection 1720 are placed in fluid communication by one or more connectors1708, the details of which are also set forth hereinafter.

The first section 1710 includes a multi-position valve 1712, for examplea 3-position stopcock valve, which is adapted to be automaticallycontrolled or actuated by the valve actuator 1404 on the fluid controlmodule 1400. The multi-position valve 1712 is adapted to selectivelyisolate the syringe 1702, the primary fluid container 1704, and thesecond section 1720 to selectively allow the injector 1300 to fill thesyringe 1702 with fluid from the primary fluid container 1704, deliverthe fluid loaded into the syringe 1702 to the second section 1720, orisolate the syringe 1702 from the primary fluid container 1704 and thesecond section 1720. The multi-position valve 1712 is connected to thesyringe 1702 by a luer connection 1714, which may be a standard luerconnection known in the art.

The first section 1710 further includes intervening drip chambers 1716associated with the primary fluid container 1704 and the secondary fluidcontainer 1706. In FIGS. 9B and 10B, drip chambers 1716 are replaced bypriming bulbs P in the fluid path set 1700, and the fluid level sensingmechanism 1406 is altered to interface with the priming bulbs P and/ormedical tubing associated with the priming bulbs P as discussed furtherherein in connection with FIGS. 24-26. The drip chambers 1716 areadapted to be associated with primary and secondary fluid containers1704, 1706 with conventional spike members 1717. The fluid level sensingmechanism 1406 on the fluid control module 1400 is used to sense fluidlevels in the drip chambers 1716 when the fluid path set 1700 isassociated with the injector 1300 and the fluid control module 1400.Generally, operation of the fluid delivery system 1200 includes filling,loading, or “priming” the syringe 1702 with fluid from the primary fluidcontainer 1704, which passes to the syringe 1702 via the drip chamber1716 associated with the primary fluid container 1704. Similarly, duringoperation of the fluid delivery system 1200, fluid such as saline, fromthe secondary fluid container 1706 is supplied to the second section1720 via the drip chamber 1716 associated with the secondary fluidcontainer 1706. The drip chambers 1716 are generally adapted to permitfluid level sensors associated with the fluid level sensing mechanism1406 to detect the level of fluid in the drip chambers 1716, for exampleby using optical or ultrasonic methods. Respective output lines 1718made, for example, of conventional low pressure medical tubing, areassociated with the drip chambers 1716 for connecting the drip chambers1716 to the multi-position valve 1712 and the second section 1720. Theoutlet of the multi-position valve 1712 is connected to an output line1719, which is used to connect the multi-position valve 1712 and syringe1702 to the second section 1720. Due to the high injection pressurestypically generated by the injector 1300 during an injection proceduresuch as angiography, the output line 1719 is preferably constructed ofhigh pressure medical tubing. An inlet to the multi-position valve 1712is connected via an inlet line 1721 to the syringe 1702, and ispreferably also constructed of high pressure medical tubing.

The second section 1720 generally includes a pressure isolationmechanism or valve 1722. The pressure isolation mechanism 1722 isconnected by respective input lines 1724, 1726 and the connectors 1708to the first section 1710. The first input line 1724 is preferablyformed of conventional medical tubing and connects the pressureisolation mechanism 1722 with the drip chamber 1716 associated with thesecondary fluid container 1706. The second input line 1726 is preferablyformed of high pressure medical tubing and connects the pressureisolation mechanism 1722 with the output line 1719 connected to themulti-position valve 1712 and, ultimately, the syringe 1702 and primaryfluid container 1704. The tubing used for the second input line 1726 ispreferably high pressure medical tubing.

An output line 1728 is associated with the pressure isolation mechanism1722 for connecting the pressure isolation mechanism 1722 with thecatheter. A second multi-position valve 1730, for example in the form ofa stopcock valve, may be provided in the output line 1728, as a shut-offfeature. As shown in FIGS. 10A-10B, the multi-position valve 1730 may beprovided as a simple shut-off valve to isolate the catheter from thefirst section 1710 of the fluid path set 1700. The output line 1728 mayfurther include a catheter connection 1732 for associating the fluidpath set 1700 with a catheter to be used in a fluid injection procedureinvolving the fluid delivery system 1200.

Referring briefly to FIG. 11A, one of the drip chambers 1716 used in thefluid path set 1700 is shown in enlarged detail. The drip chamber 1716shown in FIG. 11A generally has an elongated body 1734 with a top end1736 and a bottom end 1738. The body 1734 is formed with a projection1740, which generally extends longitudinally along the body 1734, or inany configuration on the body 1734 of the drip chamber 1716, and mayeven be in the form of a handle with an opening such as those found onplastic bottles. The projection 1740 is generally provided to interactwith the fluid level sensing mechanism 1406 on the fluid control module1400, and may be referred to as a “back” window because the projection1740 will generally face the fluid level sensors in the fluid levelsensing mechanism 1406 when the drip chamber 1716 is associated with thefluid level sensing mechanism 1406. FIG. 11B illustrates an alternativedrip chamber 1716′ which has a tapered or domed upper end 1741 whichlimits the accumulation of air bubbles in drip chamber 1716′ and,further, facilitates easy expulsion of air bubbles during priming of thedrip chamber 1716′ during operational set-up of fluid path set 1700,which is discussed in detail herein. The use of alternative drip chamber1716′ is identical to that of drip chamber 1716 and each are shownassociated with fluid level sensing mechanism 1406 in FIGS. 24-26discussed herein.

The body 1734 is preferably formed of a plastic material and, moreparticularly, a resiliently deformable medical-grade plastic material toallow in-place “priming” of the drip chamber 1716, when the drip chamber1716 is associated with the fluid level sensing mechanism 1406. Thefluid level sensing mechanism 1406 is generally adapted to support andsecure the drip chambers 1716, as shown in FIG. 9A. The projection 1740further permits the drip chamber 1716 to be primed in place in the fluidlevel sensing mechanism 1406. The plastic material comprising the body1734 may be substantially clear or slightly opaque, but the projection1740 is preferably clear to allow an optical fluid level sensor in thefluid level sensing mechanism 1406 to detect the fluid level in the dripchamber 1716. The projection 1740 is preferably raised from the body1734 of the drip chamber 1716 to allow priming of the drip chamber 1716.Generally, the body 1734 of the drip chamber 1716 is sufficiently clearto allow light transmission from lighting associated with the fluidlevel sensing mechanism 1406. The body 1734 of the drip chamber 1716will generally act as a light conduit or “light pipe” that willilluminate the fluid flow path in the medical tubing forming the outputlines 1718 associated with the drip chambers 1716 connected to theprimary and second fluid containers 1704, 1706.

Referring to FIGS. 12-15, the pressure isolation mechanism 1722 is shownin greater detail. The pressure isolation mechanism 1722 includes ahousing 1742. The housing 1742 may be a unitary housing or, preferably,a multi-piece housing as shown in FIG. 13. Preferably, the housing 1742is a two-piece housing including a first portion 1744 and a secondportion 1746, which are adapted to connect together to form the housing1742. The first and second portions 1744, 1746 are preferably formed forinterference engagement with each other.

The interference engagement is formed by engagement of a dependingannular flange 1748 formed on the first portion 1744 of the housing 1742with a corresponding recess or groove 1749, for example, a circularrecess or groove, formed or defined in the second portion 1746 of thehousing 1742. The recess 1749 is purposely made slightly smaller inwidth than the thickness of the annular flange 1748, so that when thefirst and second portions 1744, 1746 of the housing 1742 are joinedtogether there is interference engagement between the annular flange1748 and the recess 1749. The second portion 1746 of the housing 1742may include a raised annular flange 1750 that engages or cooperates witha corresponding recess or groove 1751 defined in the first portion 1744.The raised annular flange 1750 may engage with the recess 1751 in asimilar friction fit manner as the annular flange 1748 and recess 1749discussed previously. The combination of the annular flanges 1748, 1750and recesses 1749, 1751 generally define a shear interface 1752 betweenthe first and second portions 1744, 1746 of the housing 1742, whichincreases their assembly strength. An adhesive or ultrasonic weld may beused along the shear interface 1752 to secure the first and secondportions 1744, 1746 together. The connection between the flanges 1748,1750 and the recesses 1749, 1751 generally define a tortuous path alongthis connection line.

The first portion 1744 of the housing 1742 defines a primary or highpressure lumen 1754, which forms a high pressure side of the pressureisolation mechanism 1722. An inlet 1755 to the high pressure or primarylumen 1754 is in fluid communication with the second input line 1726,which is the high pressure line connecting the pressure isolationmechanism 1722 with the output line 1719 associated with themulti-position valve 1712 and, ultimately, the syringe 1702 and theprimary fluid container 1704. An outlet 1756 of the primary lumen 1754is connected to the second multi-position valve 1730, which may beprovided in the output line 1728 as discussed previously.

The second portion 1746 of the housing 0.1742 defines a secondary or lowpressure lumen 1758, which generally forms a low pressure side of thepressure isolation mechanism 1722. The secondary lumen 1758 has an inlet1759 that is in fluid communication with the first input line 1724,which is the low pressure line that connects the pressure isolationmechanism 1722 to the secondary fluid container 1706 via the peristalticpump 1408 on the fluid control module 1400 and drip chamber 1716. Thesecond portion 1746 of the housing 1742 includes a vent hole 1760provided for proper operation of the pressure isolation mechanism 1722.The second portion 1746 of the housing 1742 further includes a pressureisolation port 1761 to which a pressure transducer (See FIGS. 7B through7F) may be connected. The structure forming the pressure isolation port1761 may terminate in a luer connector for connecting a pressuretransducer to the pressure isolation port 1761.

The first and second portions 1744, 1746 of the housing 1742 may definean internal chamber 1762, generally in fluid communication with theprimary lumen 1754 and the secondary lumen 1758. The first portion 1744of the housing 1742 may include a depending retaining member 1763extending into the internal chamber 1762. An internal valve member 1764is located in the internal chamber 1762 and is used to isolate thepressure isolation port 1761 when the pressure isolation mechanism 1722is associated with the syringe 1702, (i.e., in fluid communication withan operating syringe 1702). The valve member 1764 is generally engagedby the retaining member 1763 depending or extending from the firstportion 1744 of the housing 1742 to maintain a preload of the valvemember 1764. The valve member 1764 is generally adapted to bias thepressure isolation mechanism 1722 to a normally open position, whereinthe primary lumen 1754 is in fluid communication with the secondarylumen 1758 and the pressure isolation port 1761 through the internalchamber 1762. The valve member 1764 is generally further adapted toisolate the pressure isolation port 1761 once fluid pressure in theprimary lumen 1754 reaches a preset pressure, as described furtherherein.

The valve member 1764 is preferably a two-piece structure comprising aseat member 1766 and a base portion 1767. The seat member 1766 isgenerally adapted to seat against a seal ring 1768 formed on the secondportion 1746 of the housing 1742 in the closed position of the valvemember 1764, thereby isolating the primary lumen 1754 from the secondarylumen 1758 and the pressure isolation port 1761. The seat member 1766includes an integral biasing portion 1770. The biasing portion 1770 is agenerally conical shaped portion of the seat member 1766 that is hollowand preferably has a pre-established or preset spring force tension. Thebase portion 1767 is generally engaged by the retaining member 1763depending or extending from the first portion 1744 of the housing 1742to maintain a preload of the conical shaped biasing portion 1770 andform a seal with the body of the second portion 1746 of the housing1742, thereby preventing fluid from leaking or exiting via the vent hole1760. The vent hole 1760 allows for proper operation of the valve member1764 by allowing air to vent from the conical shaped biasing portion1770 during operation of the valve member 1764. When the pressure withinprimary lumen 1754 increases during an injection procedure, the biasingportion 1770 of the seat member 1764 responds by deforming within theinternal chamber 1762 until the seat member 1766 of the valve member1764 seats against the seal ring 1768 formed on the second portion 1746of the housing 1742. Once the seat member 1766 seats against the sealring 1768, the valve member 1764 is in a closed position. Thepre-established or preset spring force tension is preferably selected toprevent damage to the pressure transducer, saline line, or otherpressure sensitive devices typically connected to the pressure isolationport 1761 and may be pre-selected such that the valve member 1764 is inthe closed position when the fluid pressure in the primary lumen 1754 isless than 70 psi. In the closed position of the valve member 1764, theprimary lumen 1754 is isolated from the secondary lumen 1758 and thepressure isolation port 1761.

As FIG. 14 shows, the seat member 1766 may define an opening 1772 forreceiving a tab or projection 1773 on the base portion 1767 forconnecting the base portion 1767 to the seat member 1766. The seatmember 1766 and base portion 1767 may be secured together by mechanicaldevices (i.e., fasteners), adhesively secured together, or bondedtogether when the valve member 1764 is formed. For example, the seatmember 1766 and the base portion 1767 may be formed of differentpolymeric materials that will adhere to one another, for example, whenelevated heat or pressure re applied. For example, the seat member 1766may be made of a thermoplastic elastomer and the base portion 1767formed of a polypropylene that will adhere to the thermoplasticelastomer when the seat member 1766 and the base portion 1767 are moldedtogether.

FIGS. 48-52 illustrate a further aspect of pressure isolation mechanism1722. As will be clear from the foregoing, pressure isolation mechanism1722 is the merge point for contrast and saline for delivery to apatient during a fluid injection or delivery procedure. One aspect ofpressure isolation mechanism 1722 relates to using a pressure transducerassociated with pressure isolation port 1761 to take hemodynamic bloodpressure signal readings and obtain other relevant informationassociated with the fluid delivery procedure involving the delivery ofcontrast and/or saline to the patient. As is known from the foregoing,valve member 1764 provides automatic overpressure protection to thistransducer during delivery of contrast at high pressure to the pressureisolation mechanism.

The pressure isolation mechanism 1722 as configured and explainedpreviously provides accurate undamped hemodynamic pressure readings whensaline is present between the patient and the pressure transducerassociated with pressure isolation port 1761. However, it is alsodesirable to provide an undamped signal when contrast is present betweenthe patient and the pressure transducer. Generally, hemodynamic pressuresignals are damped by the presence of air bubbles, thicker fluid mediasuch as contrast, medical tubing lengths, internal diameters, andoverall system and tubing compliance. The variation of pressureisolation mechanism 1722 illustrated in FIGS. 48-52 significantlyreduces the dampening of the hemodynamic pressure signals when contrastis present by substantially isolating the compliant tubing associatedwith the saline, low pressure “side” of the pressure isolation mechanism1722 from the pressure transducer associated with the pressure isolationport 1761. This is accomplished in one variation by substantiallyisolating the compliant tubing and other upstream elements associatedwith low pressure or secondary lumen 1758 with a valve arrangement 2100disposed in this lumen. The valve arrangement 2100, as will be clearfrom the following description, allows fluid flow in two directions(bilaterally) in the secondary lumen 1758 carrying saline but fluid flowdoes not start until pressures are above any blood pressure readings.

In general, in the pressure isolation mechanism 1722, outlet port 1756of primary lumen 1754 is associated with a patient, inlet port ofprimary lumen 1755 is associated with syringe 1702 and high pressurefluid injector 1300, and inlet port 1759 of secondary lumen 1758 isassociated with the low pressure saline delivery system includingperistaltic pump 1408. Valve arrangement 2100 is generally associatedwith inlet port 1759 of secondary lumen, 1758 and isolates the“compliant” system components of the low pressure saline fluid deliverysystem from hemodynamic blood pressure signals from the patient. As aresult, these readings are substantially undamped and accurate readingmay be taken via a pressure transducer (See FIG. 7C) associated withpressure isolation port 1761.

The valve arrangement 2100 comprises an adaptor sleeve 2110 which issized for mating engagement with the inlet portion or port 1759 ofsecondary lumen 1758. Adaptor sleeve 2110 may be an injection moldedstructure and defines a lumen 2112 therethrough adapted to accept themedical tubing forming first input line 1724, which may be adhesivelysecured in lumen 2112. A stop 2114 is formed in lumen 2112 to limitinsertion of first input line 1724 in adaptor sleeve 2110. Adaptorsleeve 2110 secures a disk valve 2116 in place within inlet port 1759and across secondary lumen 1758. Disk valve 2116 regulates fluid flowbi-laterally through secondary lumen 1758 and desirably comprises astamped disk valve member 2118 made from a flexible thermoplasticmaterial that has one or more slits or openings 2120 through the body ofthe disk valve member 2118. The number of slits 2120 and length of theslits 2120 control the pressure necessary to achieve flow in bothdirections (bilaterally). Slit disk valves achieve flow control bychanging one or more of several design factors as is well-known in theart. For example, slit or passageway opening pressure may be affected bychoice of material for the disk valve member 2118, number of slits 2120,length of slits 2120, freedom of deflection/deformation permitted insecondary lumen 1758 and/or inlet port 1759, and diameter of thesecondary lumen 1758 and inlet port 1759.

In operation, disk valve 2116 allows fluid flow in both directions andstop 2114 is typically spaced a short distance away from the disk valvemember 2118 to provide sufficient spacing or room to allow the diskvalve member 2118 to deflect or deform under fluid pressure wherebyslits 2120 open and allow fluid flow therethrough. On the opposite sideof the disk valve 2116, the secondary lumen 1758 may be formed with ashoulder 2122 to restrain the movement or deflection of the disk valvemember 2118 in the secondary lumen 1758. While the sandwichedarrangement of disk valve member 2118 between shoulder 2122 and stop2114 may be sufficient to fix the location of the disk valve 2116 inport 1759, it is desirable to use a medical grade adhesive around theperiphery of disk valve member 2118 to secure the disk valve member 2118in inlet port 1759 and across secondary lumen 1758. If desired, a smallin-line porous filter valve 2119 may be provided in secondary lumen 1758to add back pressure to limit on pulsatile flow of peristaltic pump 1408and slow down the initial burst of air and fluid when the disk valve2116 initially operates or opens. FIGS. 50A-50C illustrate disk valvemember 2118 with one, two, and three slits 2120, respectively, allow forthe changing of opening pressure for valve arrangement 2100. Stop 2114is generally tapered to allow for the deflecting/deforming movement ofdisk valve member 2118 in lumen 2112 during operation of disk valve2118. Disk valve 2118 generally forms a “second” valve structure inpressure isolation mechanism 1722 in addition to the “first” valvestructure in pressure isolation mechanism 1722 in the form of valvemember 1764.

As shown in FIGS. 51-52, sleeve adaptor 2110 is formed with a tubularbody portion 2124 that defines lumen 2112 and an integral annular collar2126 which extends along the outer side of the tubular body portion2124. Annular collar 2126 engages or receives the tubular portion of thelower or second portion 1746 of valve housing 1742 which defines thesecondary lumen 1758 and inlet port 1759. Annular collar 2126 defines anannular space 2128 for receiving the inlet port 1759 defined by thetubular portion of the second portion 1746 of valve housing 1742. Inletport 1759 may be secured in annular space 2128 via medical gradeadhesive and/or frictional engagement. As revealed by FIGS. 51-52 andFIG. 49, disk valve member 2118 may be formed with a continuous (oralternatively interrupted) recess or groove 2130 adapted to receive asingle continuous tab member 2132 (or multiple, discrete tab members2132) provided on a distal end 2134 of the tubular body portion 2124 ofthe sleeve adaptor 2110. This inter-engagement between the tab member2232 and the recess or groove 2130 in the disk valve member 2118 helpsto secure the engagement between disk valve 2116 and sleeve adaptor 2110in inlet port 1759. The inter-engagement between the tab member 2232 andthe recess or groove 2130 in disk valve member 2118 may be supplementedwith a medical grade adhesive if desired.

FIGS. 53-57 illustrate various additional embodiments of valvearrangement 2100. In FIG. 53, sleeve adaptor 2110 just comprises atubular body portion 2124 which is inserted and secured entirely withininlet port 1759. Disk valve 2116 is secured to the distal end 2134 oftubular body portion 2124 of sleeve adaptor 2110 in the same manner asdescribed previously. In this embodiment, it is possible for the diskvalve 2116 and tubular body portion 2124 to be integrally formed as aunitary element. The tubular body portion 2124 of sleeve adaptor 2110serves as a limit or stop limiting the insertion of first input line1724 in inlet port 1759. In FIG. 53, inlet port 1759 exhibits a steppedconfiguration in the vicinity of the distal end 2134 of tubular bodyportion 2124 and the tubular body portion 2124 defines a correspondingstepped shape to provide inter-fitting engagement or cooperation betweenthese structures.

FIG. 54 illustrates an embodiment of valve arrangement 2100 which issimilar to the valve arrangement 2100 of FIG. 49 but the sleeve adaptor2110 lacks annular collar 2126. In this embodiment, a portion or lengthof the tubular body portion 2124 at distal end 2134 is secured in inletport 1759 via medical grade adhesive and/or frictional engagement. Theremainder of tubular body portion 2124 extends outward from inlet port1759 and forms the portion of pressure isolation mechanism 1722 whichaccepts first input line 1724. As FIG. 54 further illustrates, lumen2112 may be tapered toward first input line 1724 to minimize theproduction of air bubbles as fluid flows through sleeve adaptor 2110 andotherwise maintain laminar flow through the sleeve adaptor 2110 duringfluid flow. The valve arrangement 2100 of FIG. 55 is generally similarto that shown in FIG. 54 but an elongated adaptor structure 2136 isassociated with the sleeve adaptor 2110 and is inserted in inlet port1759 to form the fluid connection between the valve arrangement 2100 andinlet port 1759 defined by the tubular portion of the second portion1746 of valve housing 1742. Elongated adaptor structure or member 2136may be secured in inlet port 1759 via grade adhesive and/or frictionalengagement.

FIG. 56 illustrates an embodiment of valve arrangement 2100 which issimilar to the valve arrangement of FIG. 53 but the tubular body portion2124 of sleeve adaptor 2110 is truncated in overall length when comparedto the tubular body portion 2124 of the sleeve adaptor 2110 of FIG. 53.Additionally, inlet port 1759 and the distal end 2134 of tubular bodyportion 2134 do not exhibit the inter-fitting stepped engagementprovided between these structures in the valve arrangement 2100 depictedin FIG. 53. In FIG. 56, disk valve member 2118 is secured in inlet port1759 on one side by shoulder 2122 defined in inlet port 1759 and theother side by adhesive engagement between tubular body portion 2124 ofsleeve adaptor 2110 and the inlet port 1759 and, more clearly, thetubular portion of the second portion 1746 of valve housing 1742 whichdefines the inlet port 1759. As shown in FIG. 56, an entire length L₁ ofthe tubular body portion 2124 may be secured within inlet port 1759.FIG. 57 illustrates a further embodiment of valve arrangement 2100wherein sleeve adaptor 2110 and disk valve 2116 are formed integrally asa unitary structure which is position and secured in place in inlet port1759 or, as illustrated, in secondary lumen 1758 via medical gradeadhesive and/or frictional engagement. In a similar manner to that shownin FIG. 56, an entire length L₂ of the tubular body portion 2124 may besecured within secondary lumen 1758, typically by adhesive. While forforegoing discussion of valve arrangement 2100 is provided in thecontext of pressure isolation mechanism 1722, valve arrangement 2100 mayuseful in any fluid delivery setting wherein it is desired tosubstantially isolate compliant “upstream” system elements fromaffecting a downstream parameter such as blood pressure signals in theforegoing example.

FIGS. 16-19 illustrate the reduced or anti-contamination connector 1708used to connect the first section 1710 and second section 1720 in thefluid path set 1700 shown in FIGS. 10A-10B in greater detail. As shownin FIGS. 10A-10B discussed previously, one connector 1708 connects thehigh pressure, second input line 1726 associated with the pressureisolation mechanism 1722 with the high pressure output line 1719 fromthe multi-position valve 1712 associated with controlling fluid flowfrom the syringe 1702. A second connector 1708 connects the lowpressure, first input line 1724 associated with the pressure isolationmechanism 1722 to the output line 1718 associated with the drip chamber1716 connected to the secondary fluid container 1706.

The connector 1708 generally includes a first connector member 1774 thatis adapted for removable connection to a second connector member 1776.The first and second connector members 1774, 1776 are designed orstructured to reduce the possibility of contaminating the internalelements of the first and second connector members 1774, 1776 when theyare handled by a user of the connector 1708. The first and secondconnector members 1774, 1776 are preferably unitary structures that areintegrally formed from plastic material, such as a medical-grade plasticmaterial capable of resisting pressures generated during injectionprocedures such as angiography. The first and second connector members1774, 1776 are preferably formed with external wings 1775 for graspingby a user of the connector 1708 while manipulating the first and secondconnector members 1774, 1776, particularly when connecting the first andsecond connector members 1774, 1776 together. As discussed herein, thefirst and second connector members 1774, 1776 preferably includestructures that provide a removable threaded engagement between thefirst and second threaded members 1774, 1776. The wings 1775 generallyprovide the mechanical advantage necessary to tighten the preferredthreaded engagement between the first and second connector members 1774,1776. The first connector member 1774 defines a central lumen 1777 thatextends entirely through the first connector member 1774. Likewise, thesecond connector member 1776 defines a central lumen 1778 extendingentirely through the second connector member 1776, so that when thefirst and second connector members 1774, 1776 are connected, fluidcommunication is established therebetween via lumens 1777, 1778.

The first connector member 1774 includes an outer housing 1780. Theouter housing 1780 is, generally a cylindrical shaped hollow structureand may have a smooth or textured outer surface 1781. The firstconnector member 1774 further includes a first threaded member 1782located within the outer housing 1780. The first threaded member 1782may be coaxially located within the outer housing 1780. As shown in FIG.17, the lumen 1777 in the first connector member 1774 extends throughthe first threaded member 1782. The first threaded member 1782 ispreferably externally threaded and may be in the form of an externallythreaded female luer fitting. The first threaded member 1782 is recessedwithin the outer housing 1780 by a recessed distance R₁, as shown inFIG. 18. The recessed distance R₁ is preferably sufficient to preventcontact with the end or tip of the first threaded member 1782 when aperson touches the end or tip of the first connector member 1774. Therecessed distance R₁ thereby reduces the possibility of contaminatingthe first threaded member 1774, when the first connector member 1774 ismanipulated by a user of the connector 1708. In particular, the recesseddistance R₁ is of sufficient distance that human skin on a person'sfinger or thumb will not penetrate to the depth of the first threadedmember 1782 and come into contact with the end or tip of the firstthreaded member 1782.

The second connector member 1776 includes a second threaded member 1784,which generally forms the connecting portion or structure of the secondconnector member 1776. The second threaded member 1784 is preferablyinternally threaded to receive the externally threaded first threadedmember 1782 for connecting the first and second connector members 1774,1776 together in removable engagement. The first threaded member 1782may be in the form of an externally-threaded female luer. The secondconnector member 1776 further includes a luer fitting 1786 located inthe second threaded member 1784. The luer fitting 1786 is preferably inthe form of a male luer adapted to cooperate with the first threadedmember 1782 when the first connector member 1774 is connected to thesecond connector member 1776. The luer fitting 1786 is preferablycoaxially disposed in the second threaded member 1784. The lumen 1778 inthe second connector member 1776 extends entirely through the luerfitting 1786. The luer fitting 1786 is recessed within the secondthreaded member 1784 by a recessed distance R₂, in a similar manner tohow the first threaded member 1782 is recessed within the outer housing1780. The second threaded member 1784 further includes one or morecircumferentially-extended raised structures 1788, such as rings, on anouter surface 1789 thereof.

FIG. 17 shows the connection between the first and second connectormembers 1774, 1776 forming the connector 1708. In the connectedarrangement of the first and second connector members 1774, 1776, thefirst threaded member 1774 is secured to the second connector member1776 by removable threaded engagement between the externally threadedfirst threaded member 1782 and the internally threaded second threadedmember 1784. The luer fitting 1786 recessed within the second threadedmember 1784 cooperates with the first threaded member 1782 to providefluid communication between the first and second connector members 1774,1776. The present invention is not intended to be limited to thespecific connection arrangement shown in FIG. 17, and the locations ofthe first threaded member 1782 and the second threaded member 1784 maybe reversed in accordance with the present invention. Thus, the firstthreaded member 1782 may be provided on the second connector member 1776and the second threaded member 1784 may be provided on the firstconnector member 1774.

In the connected arrangement between the first and second connectormembers 1774, 1776, the first threaded member 1782 and the secondthreaded member 1784 are threadably engaged and coaxially overlap oneanother. The outer housing 1780 of the first connector member 1774generally encompasses the connection between the first and secondthreaded members 1782, 1784. In particular, the outer housing 1780generally coaxially encompasses the overall connection between the firstand second threaded members 1782, 1784. The outer housing 1780 has aninternal wall or surface 1790 located opposite from the outer surface1789 of the second threaded member 1784, when the first and secondthreaded members 1782, 1784 are threadably engaged. As FIG. 18illustrates, the inner wall or surface 1790 of the outer housing 1780and the first threaded member 1782 generally define an annular cavity1791 about the first threaded member 1782, in which the second threadedmember 1784 is generally received when the first and second threadedmembers 1782, 1784 are threadably engaged. The distance between theinner wall or surface 1790 of the outer housing 1780 and the firstthreaded member 1782 in the annular cavity 1791 is preferably sufficientto receive at least the overall wall thickness of the second threadedmember 1784, including the raised structures 1788 on the outer surface1789 of the second threaded member 1784 as generally depicted in FIG.17.

In the connected arrangement of the first and second connector members1774, 1776, the annular cavity 1791 is substantially enclosed by thesecond threaded member 1784 to form a substantially enclosed chamber1792. The chamber 1792 is generally bounded by the body of the firstthreaded member 1782, the inner wall or surface 1790 of the outerhousing 1780, and the end or tip of the second threaded member 1784. Thechamber 1792 is generally adapted to trap liquids, such as blood orcontrast media, therein that may spill or leak from the first and secondthreaded members 1774, 1776, when they are connected or disconnected toconnect or disconnect the first and second sections 1710, 1720 of thefluid path set 1700, for example during or after an angiographyprocedure.

The first connector member 1774 and second connector member 1776 definerespective conduit-receiving cavities 1794, 1793 at the ends of thefirst and second connector members 1774, 1776 opposite from the firstthreaded member 1782 and the second threaded member 1784, respectively.The conduit-receiving cavities 1794, 1793 are generally adapted toreceive medical tubing to be associated with the first and secondconnector members 1774, 1776. The medical tubing may be secured in theconduit-receiving cavities 1793, 1794 through the use of an appropriatemedical-grade adhesive. The primary and secondary lumens 1754, 1758 maybe formed with similar conduit-receiving cavities for receiving medicaltubing used to connect the pressure isolation mechanism 1722 to othercomponents in the fluid path set 1700. A suitable medical-grade adhesivemay be used in such cavities to secure the medical tubing. Similarstructures and connections may also be provided in the inlet and outletports of the drip chambers 1716.

As indicated previously, in the connected arrangement of the first andsecond connector members 1774, 1776, the liquid-trapping chamber 1792 isformed, and is generally used to trap liquids that may spill or leakfrom the first and second connector members 1774, 1776, when they areconnected or disconnected during or after an injection procedureinvolving the fluid path set 1700. The raised structures 1788 on theouter surface 1789 of the second connector member 1784 are adapted toform a tortuous path 1795 for inhibiting liquid flow out of or into theliquid-trapping chamber 1792. Thus, liquid-trapping generally meansinhibiting liquid flow rather than fully containing liquid. The tortuouspath 1795 will generally cause liquids present or leaking into thechamber 1792 to remain in the chamber 1792, and will further inhibitoutside liquid from migrating into the sterile connection between thefirst threaded member 1782 and the second threaded member 1784. Bymaintaining contaminated liquids in the chamber 1792 or generallybetween the inner surface 1790 of the outer housing 1780 and the outersurface of 1780 of the second threaded member 1784, the sterility of theconnection between the luer fitting 1786 and the first threaded member1782 is generally maintained. Additionally, even when the firstconnector member 1774 is disconnected from the second connector member1776, the annular cavity 1791 about the first threaded member 1782 willact to maintain any contaminated liquids generally within the outerhousing 1780, and maintain the sterility of the luer fitting 1786 withinthe second threaded member 1784. Thus, the second connector member 1776may be re-used in a connection arrangement involving a different firstconnector member 1774.

Referring to FIGS. 18 and 19, the first and second connector members1774, 1776 may be formed with circumferentially-extending raised ribs1796 adapted to secure removable protector caps 1798 on the first andsecond connector members 1774, 1776 prior to connecting the first andsecond connector members 1774, 1776. FIGS. 18 and 19 show the protectorcaps 1798 engaged with the first and second connector members 1774,1776. The protector caps 1798 define circumferentially-extendinginternal grooves or recesses 1799 for receiving the raised ribs 1796 onthe first and second connector members 1774, 1776. The raised rib 1796on the first and second connector members 1774, 1776 are preferablyadapted to frictionally engage the grooves or recesses 1799 formed inthe protector caps 1798 to maintain the protector caps 1798 on the firstand second connector members 1774, 1776. The protector caps 1798generally maintain the sterility of the first and second threadedmembers 1782, 1784 prior to connecting the first and second connectormembers 1774, 1776 together.

Referring further to FIG. 19, the protector caps 1798 may be used tocover the first and second connector members 1774, 1776 of theconnectors 1708 in the fluid path set 1700 before and after injectionprocedures involving the fluid path set 1700. Thus, the first and secondsections 1710, 1720 of the fluid path set 1700 may be kept disconnectedprior to an injection procedure when the fluid delivery system 1200 isbeing readied to carry out an injection procedure. Moreover, when aninjection procedure is complete, additional, sterile protector caps 1798may be used to cover the first or second connector members 1774, 1776 inthe connectors 1708 associated with the first section 1710 of the fluidpath set 1700, so that this portion of the fluid path set 1700 may bereused.

As the connector 1708 of the present invention generally includes amale-threaded first connector member 1774 and a female-threaded secondconnector member 1776, the male-threaded/female-threaded orientation ofthe first and second connector members 1774, 1776 may be used as atactile, physical indicator to prevent the high pressure primary inputline 1726 to the pressure isolation mechanism 1722 from beingincorrectly connected to the output line 1718 associated with thesecondary fluid container 1706. Similarly, and more importantly, thisfeature may be used to prevent the low pressure, second input line 1724to the pressure isolation mechanism 1722 from being incorrectlyconnected to the high pressure output line 1719 associated withmulti-position valve 1712 controlling flow rate from the syringe 1702.As FIGS. 10A-10B illustrate, the locations of the first and secondconnector members 1774, 1776 are reversed in the connectors 1708 used inthe fluid path set 1700, which will prevent inadvertent, incorrectcross-connections between the first and second sections 1710, 1720 inthe fluid path set 1700.

Referring further to FIGS. 37-47, another embodiment of the connectors1708′ used to connect the first and second sections 1710, 1720 in thefluid path set 1700 depicted in FIGS. 10A-10B are shown. The connectors1708′ includes first and second connector members 1774′, 1776′, whichare now configured slightly differently from the connector members 1774,1776 discussed previously. These differences will be discussed withreference to FIGS. 37-47 and FIGS. 10A-10B and 16-19 discussedpreviously.

The first connector member 1774′ is now formed with aninternally-threaded outer housing 1780′ in comparison to the outerhousing 1780 of the previous embodiment of the connector 1708, which isessentially smooth-bored. The inner wall or surface 1790′ of the outerhousing 1780′ defines internal threads 2000. The outer surface 1781′ ofthe outer housing 1780′ may have a smooth texture as illustrated in FIG.37, or include longitudinally-extending raised ribs 2002 as illustratedin FIG. 42 to be discussed herein.

An additional difference between the first connector member 1774 of theconnector 1708 discussed previously and the present embodiment of theconnector 1708′ relates to the configuration of the first threadedmember 1782′. The first connector member 1774′ does not include externalthreads on this component. The “first member” 1782′ without externalthreads is formed substantially as a conventional female luer fitting,but is still recessed a distance R₁ within outer housing 1780′ inaccordance with the description of the first threaded member 1782hereinabove. Accordingly, this element will be referred to herein as the“first luer member 1782′”. The first luer member 1782′ and outer housing1780′ define an annular cavity 1791′ therebetween for receiving thesecond threaded member 1784′ of the second connector member 1776′ in themanner discussed previously. As the outer housing 1780′ is disposedcoaxially and concentrically about the first luer member 1782′, theouter housing 1780′ may be referred to as the “first annular member1780′” and this denotation will be used hereinafter.

With specific reference to FIGS. 41 and 42, the outer housing or firstannular member 1780′ may be adapted to rotate or “swivel” relative tothe first luer member 1782′ in the first connector member 1774′ so thatthe connector 1708′ may be a “swiveling” connector. As shown in thesetwo figures, the first annular member 1780′ includes an annular flange2004 that cooperates or engages a circumferentially extending recess2006 defined adjacent the first luer member 1782′. The flange 2004 mayrotationally slide in recess 2006 so that the first annular member 1780′may rotate or swivel relative to the first luer member 1782′.

As discussed previously, the fluid path set 1700 includes two connectors1708′ for connecting the first and second sections 1710, 1720 in thefluid path set 1700. The rotational or swiveling feature of the firstannular member 1780′ allows the first connector member 1774′ in each ofthe connectors 1708′ to be joined to the second connector member 1776′in each of the connectors 1708′ without disturbing or altering theorientation of the respective input/output lines 1718, 1724 and 1719,1726 associated with the connectors 1708′ (see FIGS. 10A-10B). Forexample, the connector 1708′ associated with the high pressureinput/output lines 1719, 1726 connected to the syringe 1702 may bejoined with the “swivel” connector 1708′ so that the orientation of thedownstream pressure isolation mechanism 1722 is undisturbed. Thus, oncethe downstream orientation of the pressure isolation mechanism 1722 isset to a desired orientation by an operator of the fluid delivery system1200, the swiveling feature of the first connector member 1774′ may beused as a way of ensuring that this desired orientation is maintained.Without this swivel feature, it is possible that rotational force may beapplied to the pressure isolation mechanism 1722 when the first andsecond connector members 1774′, 1776′ are joined in the two connectors1708′ used in the fluid path set 1700, causing the pressure isolationmechanism 1722 to be rotated to an undesirable position. For example, anoperator of the fluid delivery system 1200 may elect to have thepressure isolation port 1761 of the pressure isolation mechanism 1722 tobe positioned to point toward the operator, as is the orientation ofthis component in FIGS. 10A-10B. Due to the swiveling feature of thefirst annular member 1780′ of the first connector member 1774′ in thetwo connectors 1708′ used in the fluid path set 1700, the operator canensure that a desired orientation of the pressure isolation mechanism1722 may be maintained when the respective pairs of input/output lines1718, 1724 and 1719, 1726 are joined by the connectors 1708′. Theswiveling feature ensures that rotational force is not substantiallyapplied to the pressure isolation mechanism 1722 thereby altering itsorientation when the first and second section sections 1710, 1720 of thefluid path set 1700 are connected.

As was the case with the connectors 1708 illustrated in FIGS. 10A-10Bdiscussed previously, the connectors 1708′ used in the fluid path set1700 may reverse locations for the first and second connector members1774′, 1776′ so that the “high” pressure side of the first section 1710of the fluid path set 1700 is not inadvertently connected to the “low”pressure side of the second section 1720 of the fluid path set 1700 andvice versa. The raised longitudinal ribs 2002 on the outer housing 1780′further improve the ability of the operator to make the connectionbetween the first and second connector members 1774′, 1776′ by improvingthe frictional engagement between an operator's fingertips and the outerhousing or first annular member 1780′ when rotating the first annularmember 1780′ to threadably engage the second threaded member 1784′associated with the second connector member 1776′.

Referring further to FIGS. 37-47, the second connector member 1776′ isnow specifically adapted to threadably engage the internal threads 2000provided on the inner surface 1790′ of the outer housing or firstannular member 1780′. The second threaded member 1784′, which may bereferred to as “second annular member 1784′” in an analogous manner tothe first annular member 1780′, is now formed with external threads 2004on the external surface 1789′ of the second annular member 1784′ forengaging the internal threads 2000 within the first annular member 1780′of the first connector member 1774′. The external threads 2004functionally take the place of the internal threads in the secondthreaded member 1776 in the previous embodiment of the connector 1708.In the previous embodiment, the internally threaded second threadedmember 1784 threadably engages the externally threaded first threadedmember 1782 to connect the first and second connector members 1774,1776. The external threads 2004 in the present embodiment are formed inplace of the raised structures 1788 in the previous embodiment, and nowthreadably engage the internal threads 2000 within the first annularmember 1780′ to connect the first and second connector members 1774′,1776′.

In addition to securing the threaded engagement between the first andsecond connector members 1774′, 1776′, the external threads 2004generally perform the function as the raised structures 1788, namelyforming a tortuous path (not shown) or tortuous barrier for inhibitingor substantially preventing liquid flow out of or into liquid-trappingchamber 1792′. The tortuous path formed by the external threads 2004 nowacts to substantially prevent liquid flow rather than just inhibitingliquid flow as was the case in the previous embodiment of the connector1708. This is because the engagement between the internal and externalthreads 2000, 2004 substantially closes off the liquid-trapping chamber1792′ in a substantially liquid tight manner, whereas the raisedstructures 1788 in the previous embodiment of the connector 1708 definea tortuous path 1795 that substantially inhibits liquid flow into andout of chamber 1792, rather than substantially sealing off chamber 1792as is substantially the case in the present embodiment.

The second connector member 1776′ also includes a recessed luer fittingor member 1786′, for example a male luer fitting, that is adapted toengage the first luer member 1782′ which, as indicated previously, maybe formed as a female luer fitting. This “second” luer member 1786′ isrecessed within the second annular member 1784′ by a distance R₂ in asimilar manner to the previously discussed embodiment of the connector1708. The first and second connector members 1774′, 1776′ are eachadapted to receive a protector cap 1798 (see FIGS. 18 and 19) in themanner discussed previously.

As shown in FIG. 47, the first and second luer members 1782′, 1786′ arenot required to be recessed within the first and second annular member1780′, 1784′ and may extend substantially flush with the first andsecond annular members 1780′, 1784′. Additionally, it may beadvantageous for only one of the first and second luer members 1782′,1786′ to be recessed within the first and second annular members 1780′,1784′. For example, FIG. 47 shows the first luer member 1782′ extendedto be substantially flush with the first annular member 1780′ forincreased positive locking engagement (i.e., increased surface area ofengagement) with the second luer member 1786′. The first annular member1780′ provides a gripping surface for an operator's fingertips and willhelp ensure that contact is not made with the first luer member 1782′.In this situation, the second luer member 1786′ may be recessed asindicated previously. However, the second luer member 1786′ may beextended to be flush with the second annular member 1786 as shown inphantom lines in FIG. 47. In view of the foregoing, the first and secondluer members 1782′, 1786′ may both be recessed or substantially flushwith respect to the first and second annular members 1780′, 1784′, oronly one of the first and second luer members 1782′, 1786′ may berecessed within the first and second annular members 1780′, 1784′ whilethe other is substantially flush with the first and second annularmembers 1780′, 1784′. These same optional combinations may be applied inan analogous manner to the connector 1708 discussed previously.

To join the first and second connector members 1774′, 1776′ together,the user inserts the second annular member 1784′ partially into firstannular member 1780′ of the first connector member 1774′ until theexternal threads 2004 on the second annular member 1784′ contact andbegin to engage the internal threads 2000 provided on the inner surface1790′ of the first annular member 1780′. Once in position, the user maybegin rotating the first annular member 1780′ so that the opposingexternal and internal threads 2004, 2000 associated with the secondannular member 1784′ and first annular member 1780′, respectively,engage and draw the first and second connector members 1774′, 1776′ intothreaded engagement. As the first and second connector members 1774′,1776′ are drawn together, the second luer member 1786′ typicallyrecessed within the second annular member 1784′ is received in the firstluer member 1782′, thereby completing the fluid connection betweenlumens 1777′, 1778′. It will be understood that the present invention isintended to include a reversed configuration for the “male” second luermember 1786′ and “female” first luer member 1782′. In such a reversedconfiguration, the male second luer member 1786′ may be formed as afemale luer fitting, and the first luer member 1782′ may be formed as amale luer fitting.

The connectors 1708′ used in the fluid path set 1700 may further includea check valve arrangement 2010 for limiting flow through the connectors1708′. The check valve arrangement 2010 may be disposed within lumen1777′ of the first connector member 1774′, or lumen 1778′ in the secondconnector member 1776′ depending on which direction through theconnector 1708′ it is desired to limit flow.

The check valve arrangement 2010 is provided in one or both of theconnectors 1708′ used to connect the first section 1710 to the secondsection 1720 of the fluid path set 1700 to isolate the first section1710 from the second section 1720 unless pressure is present in thelines of the first section 1710. More particularly, the check valvearrangement 2010 in the connectors 1708′ isolates one or both outputlines 1724, 1726 (see FIGS. 10A-10B) from one or both correspondinginput lines 1718, 1719 associated with the connectors 1708′ whenpressure is not present in input lines 1718, 1719. In this disclosure,it will be assumed that the check valve arrangement 2010 is provided inboth connectors 1708′ in the fluid path set 1700.

The check valve arrangement 2010 associated with the connectors 1708′ isnormally closed until fluid pressure in the connectors 1708′ issufficient to open the respective check valve arrangements 2010permitting flow through the connectors 1708′. Such pressure is suppliedby the peristaltic pump 1408, discussed herein connection with FIG. 27,associated with input line 1718 and the syringe 1702 associated withinput line 1719. For example, the connector 1708′ associated with inputline 1718 may be configured such that the first connector member 1774′of the connector 1708′ is associated with input line 1718. Input line1718 is, in turn, connected to the drip container 1716 containing asecondary injection fluid. The check valve arrangement 2010 may beprovided in the first connector member 1774′ to prevent secondaryinjection fluid from passing through the connector 1708′ untilsufficient pressure is present in input line 1718 to open the normallyclosed check valve arrangement 2010. As indicated, sufficient fluidpressure to open the check valve arrangement 2010 would be supplied bythe peristaltic pump 1408, and may be in the range of about 8-20 psi.

A check valve arrangement 2010 may be provided in the connector 1708′connecting input line 1719 with output line 1726 on the “high” pressureside of the fluid path set 1700 associated with the syringe 1702. Inthis situation, the check valve arrangement 2010 may be provided inlumen 1778′ in the second connector member 1776′. As indicatedpreviously, in order to avoid an inadvertent cross connection betweeninput line 1719 and output line 1724 and, further, a correspondinginadvertent cross connection between input line 1718 and output line1726, the locations for the first and second connector members 1774′,1776′ may be reversed in the connectors 1708′ connecting the respectiveinput lines 1718, 1719 and output lines 1724, 1726. Accordingly, if thecheck valve assembly 2010 is provided in the first connector member1774′ of the connector 1708′ associated with input line 1718, the otherconnector 1708′ associated with input line 1719 will have the checkvalve assembly 2010 provided in the second connector member 1776′ ratherthan the first connector member 1774′. The check valve assembly 2010disposed in the second connector member 1776 will open under the fluidpressure supplied by the syringe 1702, as indicated previously.

The check valve assembly 2010 will generally be discussed as it issituated within the first connector member 1774′ of the connector 1708′used to connect input line 1718 with output line 1724, but the followingdiscussion is equally applicable to the situation where the check valveassembly 2010 could be associated with the second connector member1776′. The check valve assembly 2010 is generally comprised of aretaining sleeve 2012 and check valve stopper element 2014. The sleeve2012 is disposed (i.e., inserted) within lumen 1777′ and held therein bya friction fit. The lumen 1777′ in the present embodiment of theconnector 1708′ includes an extended length conduit receiving cavity1794′, wherein the sleeve 2012 is positioned. The conduit receivingcavity 1794′ defines an internal shoulder 2016. The sleeve 2012 isdisposed within the conduit receiving cavity 1794′ of lumen 1777 so thatthe sleeve 2012 abuts the shoulder 2016. As will be appreciated, flowthough the lumen 1777′ will be in the direction of arrow 2018 when theconnector 1708′ is associated with input line 1718. Accordingly, flowthrough the lumen 1777′ will pass centrally through central bore 2020 insleeve 2012.

The first luer member 1782′ of the first connector member 1774′ definesa central opening or aperture 2022 connected to lumen 1777′. The firstconnector member 1774′ further includes at least one septum 2024 in thecentral opening 2022 which divides the central opening 2022 into two ormore output channels 2026. In the present embodiment, the firstconnector member 1774′ is illustrated with only one septum 2024 forclarity. The septum 2024 and a distal end 2028 of the sleeve 2012 defineopposing ends of a cavity 2030 adapted to receive the stopper element2014 (hereinafter “stopper 2014”). The cavity 2030 is boundedcircumferentially or perimetrically by the wall of lumen 1777′.

As shown most clearly in FIG. 39A, the second connector member 1776′ maybe may have a similar configuration to the first connector member 1774′with respect to lumen 1778′ to receive the check valve arrangement 2010.As shown in FIGS. 40, 45, and 47, the supporting septum 2024 for thecheck valve arrangement 2010 may be omitted from the second connectormember 1776′ in the connector 1708′, if desired. The distal end 2028 ofthe sleeve 2012 forms an internal shoulder in lumen 1777 against whichthe stopper seats 2014 to prevent flow through the lumen 1777 in thenormally closed condition of the check valve arrangement 2010.

Referring to FIGS. 39B and 40B, in one variation of connector 1708′, aflow interrupter F is provided on the male second luer member 1786′.Flow interrupter F operates to affect the flow of fluid entering thefemale first luer member 1782′ from the male second luer member 1786′,as shown in FIG. 40B, wherein flow direction is indicated by arrow 2018and is now from the male second luer member 1786′ to the female firstluer member 1782′. In operation, flow interrupter F induces turbulentflow in the fluid flow exiting the male second luer member 1786′ andentering an interface area A defined by or between the male second luermember 1786′ and the female first luer member 1782′ which advantageouslyhas the effect of removing or “flushing” away trapped air (if any) inthis interface area A. While flow interrupter F is shown associated withthe male second luer member 1786′ as in FIG. 39B, this structure mayalso be associated with the female first luer member 1782′ by placingthe flow interrupter F in lumen 1777′. Typically, in accordance withthis disclosure, the flow interrupter F is provided in the luer lumen(either 1777′, 1778′) which dispenses fluid into the interface area Abetween luer members 1782′, 1786′ (i.e., the upstream lumen). Flowinterrupter F may also be applied to connector 1708 illustrated in FIGS.16-19 in generally the same manner as the foregoing.

In the normally closed condition of the check valve arrangement 2010,the stopper 2014 extends between the opposing ends of the cavity 2030and seals the central bore 2020 by engaging the internal shoulder formedby the distal end 2028 of the sleeve 2012, thereby preventing flow frompassing through the first connector member 1774′ and into the secondconnector member 1776′. The stopper 2014 may be formed of a resilientlydeformable material such as, a polyethylene thermoplastic elastomer,which deforms when fluid pressure is present in central bore 2020.Preferably, the resilient material chosen for the stopper 2014 hassufficient resiliency to maintain the closure of the central bore 2020until a predetermined pressure is reached in the central bore 2020 and,hence, lumen 1777′. As this predetermined “lift” or deformation pressureis reached, the stopper 2014 deforms axially a sufficient amount incavity 2030 to allow flow to pass from central bore 2020 into the cavity2030. As the stopper 2014 deforms axially it will unseat from the distalend 0.2028 of the sleeve 2012, thereby allowing flow to exit from thecentral bore 2020. As the stopper 2014 deforms axially it willsimultaneously expand radially. In order to allow fluid to freely passthrough cavity 2030 and into channels 2026, longitudinal grooves orrecesses 2032 are defined in the wall of cavity 2030 to permit liquidflow around the stopper 2014 and through the cavity 2030. The liquid maythen flow through channels 2026 to enter the second connector member1776′ and the lumen 1778′ therethrough. Once the fluid pressure isdiscontinued, for example, by the peristaltic pump 1408 shutting-off,the stopper 2014 will expand axially and again seal against the distalend 2028 of the sleeve 2012 to seal the central bore 2020 and preventfluid flow through the connector 1708′. The distal end 2028 may define acircumferential recess 2034 that will accept the stopper 2014 to improvethe seal between the stopper 2014 and sleeve 2012. Since the stopper2014 is formed of a resiliently deformable material, the stopper 2014may deform or “mold” into this recess 2034 when the pressure in lumen1777′ and central bore 2020 drops to a level sufficient to cause enoughaxial deformation of the stopper 2014 to cause the stopper 2014 tounseat from the distal end 2028 of the sleeve 2012. The check valvearrangement 2010 when used in the connector 1708′ connecting input line1718 with output line 1724 in the “secondary” side of the fluid path set1700 may take the place of the pinch valve 1410 discussed hereinafter.This is because the check valve arrangement 2010 in the first connectormember 1774′ will perform substantially the same function as the pinchvalve 1410, and may be used in combination with the pinch valve 1410 oras a replacement to the pinch valve 1410.

Referring to FIGS. 9-10 and 20-21 the fluid control module 1400 is shownin greater detail. The fluid control module or device 1400, as indicatedpreviously, generally includes a housing 1402, a valve actuator 1404, afluid level sensing mechanism 1406, a peristaltic pump 1408, anautomatic shut-off or pinch valve 1410, and an air detector assembly1412. The various components comprising the fluid control module ordevice 1400 will be discussed in detail herein.

The housing 1402 generally defines a port 1420 for associating theinjector 1300 with the fluid control module 1400. In particular, theinjector 1300 is generally mounted to the fluid control module 1400 tobe pivotal relative to the fluid control module 1400. The port 1420includes a mating structure 1422 for connecting the injector 1300 to thefluid control module 1400 and providing for the pivotal connectionbetween the injector 1300 and the fluid control module 1400. The port1420 defines an opening 1424 for passing electrical conduits (not shown)therethrough to operatively connect computer hardware provided in theinjector 1300 with computer hardware in the fluid control module 1400,so that the injector 1300 and fluid control module 1400 are electricallyconnected. While the port 1420 is shown on the side of the fluid controlmodule 1400, this configuration is just an exemplary arrangement for thepivotal connection between the injector 1300 and fluid control module1400 and other configurations are possible in accordance with thepresent invention such as mounting the injector at the top of the fluidcontrol module 1400.

The housing 1402 may be a multi-piece structure comprised of opposingsides or portions 1426, 1428 that are secured together by conventionalmechanical fasteners or similar fastening methods. The fluid controlmodule 1400 is generally adapted to support an IV pole 1430 used tosupport containers of fluids, for example the primary fluid container1704 (i.e., contrast media) and the secondary fluid container 1706(i.e., saline), the contents of which are supplied to a patient via thefluid delivery system 1200. In particular, the rear side or portion 1428of the housing 1402 is adapted to support the IV pole 1430. A handcontroller support 1432 may be connected to the front side or portion ofthe housing 1402 for supporting a hand controller used to operate thefluid delivery system 1200, as discussed further herein. Additionally,the fluid control module 1400 preferably includes a connector 1433adapted to operatively associate a hand controller with the fluidcontrol module 1400.

Referring further to FIGS. 22 and 23, the valve actuator 1404 is shownin greater detail. Generally, the valve actuator 1404 is adapted tosupport and actuate the multi-position valve 1712 associated with theprimary section 1710 of the fluid path set 1700. The multi-positionvalve 1712, as indicated previously, may be a three-position stopcockvalve. The valve actuator 1404 is generally adapted to selectively moveor actuate the multi-position valve 1712 between three set positions ofthe multi-position valve 1712, as will be discussed further herein.Generally, the valve actuator 1404 is adapted to place themulti-position valve 1712 in one of three distinct positions, including(1) an inject or open position, (2) a fill position, and (3) a closed orisolation position. In the inject position, the syringe 1702 of thefluid path set 1700 is in fluid communication with the secondary section1720 of the fluid path set 1700. In the fill position, the syringe 1702is in fluid communication with the primary fluid container 1704 via thedrip chamber 1716 associated with the primary fluid container 1704.Finally, in the closed position, the syringe 1702 is isolated from theprimary fluid container 1704 and the second section 1720 of the fluidpath set 1700. The specific components of the valve actuator 1404adapted to place the multi-position valve 1712 in the foregoingpositions or states will be discussed further herein.

As FIGS. 22 and 23 generally illustrate, the valve actuator 1404 is amulti-piece apparatus adapted to accept, support, and actuate themulti-position valve 1712. The valve actuator 1404 includes a basesupport member 1440 which is generally used to support the variouscomponents of the valve actuator 1404. The base support member 1440 maybe a machined part, for example, a machined aluminum part. A steppermotor 1442 is secured by mechanical fasteners 1443 to one side of thebase support member 1440. The stepper motor 1442 includes an outputshaft 1444 that provides the motive forces for operating the valveactuator 1404. A shaft interface 1446 is disposed on the other side ofbase support member 1440 from the stepper motor 1442, and is inoperative engagement with the output shaft 1444. The shaft interface1446 is associated with the output shaft 1444 to transfer the motortorque provided by the stepper motor 1442 to other components of thevalve actuator 1404, as discussed herein. The shaft interface 1446 maybe secured to the base support member 1440 using the same mechanicalfasteners 1443 used to secure the stepper motor 1442 to the base supportmember 1440.

The valve actuator 1404 further includes a photosensor assembly or array1448 that includes, preferably, two photosensor position sensors 1450for indicating the position of the handle of the multi-position valve1712 when associated with the valve actuator 1404, and a thirdphotosensor 1451 for indicating the presence of the multi-position valve1712 in the valve actuator 1404. The various photosensors 1450, 1451 arecarried or supported on two plates 1452 joined by a connecting member1453. The plates 1452 are secured to the base support member 1440 bymechanical fasteners 1454, such that the photosensor assembly 1448 isassociated with the shaft interface 1446. In particular, the shaftinterface 1446 includes two semi-circular structures or rings 1456, onlyone of which is shown in FIGS. 22 and 23, that interface with theposition sensors 1450 to indicate the position of the stepper motor1442. The position of the stepper motor 1442 may be correlated to theposition of the handle of the multi-position valve 1712 and, thus,reflect the operational position of the multi-position valve 1712 (i.e.,inject, fill, isolate). In particular, the semi-circular structures 1456may define windows 1457 that correlate to the three possible operationalpositions of the handle of the multi-position valve 1712. The shaftinterface 1446 further provides a hard stop that interfaces with thebase support member 1440 to prevent over-rotation of the handle of themulti-position valve 1712 during operation of the valve actuator 1404.

The shaft interface 1446 defines one or more slots 1458 for guiding anactuating member or pin 1460 into operational association with the valvepresent sensor 1451. Thus, the actuating member or pin 1460 is generallyused to indicate the presence of the multi-position valve 1712 in thevalve actuator 1404. The actuating member 1460 includes a plurality ofspokes 1461 that cooperate with the slots 1458 in the shaft interface1446. The actuating member 1460 further includes a distal structure 1462adapted to coact with the body of the multi-position valve 1712. Theengagement of the body of the multi-position valve 1712 with the distalstructure 1462 of the actuating member 1460 generally causes theactuating member 1460 to move proximally toward the base support member1440 and shaft interface 1446 and into operational engagement with thevalve present sensor 1451, which preferably, initiates a signal to thecomputer hardware/software associated with the fluid control module 1400and/or in the injector 1300 indicating the presence of themulti-position valve 1712 in the valve actuator 1404. The proximalmovement of the actuating member 1460 causes the spokes 1461 to moveinto further engagement with the slots 1458 defined in the shaftinterface 1446, which allows for the general proximal movement of theactuating member 1460 into the shaft interface 1446.

The distal structure 1462 of the actuating member 1460 cooperates withan adaptor 1464 that is formed to interface with the handle of themulti-position valve 1712. The adaptor 1464 is generally formed to matewith the handle of multi-position valve 1712 and transfer the motortorque from the stepper motor 1442 to the handle to move the handlebetween the inject, fill, and isolate positions indicated previously.The second multi-position valve 1730 depicted in FIGS. 10A-10B,discussed previously, shows a conventional stopcock valve with a handle,and is the general type of valve that the valve actuator 1404 isintended to operate in accordance with the present invention. Theadaptor 1464 defines a side opening 1465 for receiving the handle of themulti-position valve 1712.

The adaptor 1464 coaxially associates with the distal structure 1462 ofthe actuating member 1460. Additionally, the adaptor 1464 is adapted tocoact with a distal portion 1466 of the shaft interface 1446. The distalportion 1466 of the shaft interface 1446 defines the slots 1458 forreceiving the spokes 1461 of the actuating member 1460. The shaftinterface 1446 is generally used to transfer the motor torque from theoutput shaft 1444 to the adaptor 1464 to cause the rotation of thehandle of the multi-position valve 1712 to place the multi-positionvalve 1712 in the respective inject, fill, and isolate positionsdiscussed previously. As shown in FIG. 22, the output shaft 1444cooperates with a proximal portion 1467 of the shaft interface 1446, andthe adaptor 1464 is operationally associated with the output shaft 1444via the distal portion 1466 of the shaft interface 1446. The shaftinterface 1446 is generally adapted to transmit the rotary movement ofthe output shaft 1444 to the adaptor 1464 via the operational engagementbetween the distal portion 1466 of the shaft interface 1446 and theadaptor 1464. Thus, the rotary motion of the output shaft 1444 is usedto rotate the adaptor 1464 to one of the three operational positions ofthe multi-position valve 1712 when the stepper motor 1442 is activated.The position signals from the position sensors 1450 may be used tocontrol the operation of the stepper motor 1442 to selectively place themulti-position valve 1712 in one of the three operational positions. Inparticular, the computer hardware/software associated with the fluidcontrol module 1400 and/or injector 1300 may use the position signalsfrom the position sensors 1450 as input signals and control operation ofthe stepper motor 1442 based on the information contained in theposition signals (i.e., select a desired operational state for themulti-position valve 1712).

The valve actuator 1404 further includes a support assembly 1468 forsupporting the multi-position valve 1712 in the valve actuator 1404. Thesupport assembly includes a valve retainer 1469 and a housing 1470 forenclosing and supporting the valve retainer 1469. The valve retainer1469 includes three snap positions or mounts 1471 adapted to engage thebody of the multi-position valve 1712 to secure the multi-position valve1712 in the valve actuator 1404. The valve retainer 1469 may be formedof a plastic material and the housing 1470 may be formed of a morerobust material for protecting the multi-position valve 1712 and may beprovided, for example, as a machined aluminum part.

The adaptor 1464 generally extends through a central opening 1472 in thevalve retainer 1469 to engage the body of the multi-position valve 1712and, in particular, receive the handle of the multi-position valve 1712in the side opening 1465, to operatively associate the multi-positionvalve 1712 with the actuating components of the valve actuator 1404. Thevalve retainer 1469 has a proximal engagement structure 1473 thatdefines the central opening 1472. The engagement structure 1473 coactswith a mating circumferentially-extending edge 1474 on the actuator 1464so that the axial force associated with inserting the body of themulti-position valve 1712 into the snap positions 1471 is transmittedvia the actuator 1464 to the body of the shaft interface 1446 and thebase support member 1440. The axial movement associated with insertingthe multi-position valve 1712 into the valve retainer 1469 causes thebody of the multi-position valve 1712 to contact and engage the distalstructure 1462 of the actuating member 1460, thereby causing theactuating member 1460 to move proximally and operatively associate withthe valve present sensor 1451. The valve present sensor 1451, onceactivated, initiates the valve present signal to the fluid controlmodule 1400 and/or injector 1300.

The housing 1470 of the support assembly 1468 may be secured to theshaft interface 1446 and the base support member 1440 using the samemechanical fasteners 1443 used to secure the stepper motor 1442 to thebase support member 1440. The housing 1470 preferably defines multiplesemi-circular cut-outs or recesses 1475 for accommodating the body ofthe multi-position valve 1712, and generally corresponding to the snappositions or mounts 1471 formed in the valve retainer 1469. The cut-outsor recesses 1475 provide hard stops for the body of the multi-positionvalve 1712, which are provided to prevent the snap positions or mounts1471 from becoming over-stressed due to repeated insertions and removalsof multi-position valves 1712 into and out of the valve actuator 1404.The valve actuator 1404, after being assembled to include all of thevarious components discussed hereinabove, may be installed as a unit inthe fluid control module 1400.

Generally, when the body of the multi-position valve 1712 is insertedinto the valve retainer 1469 and engaged with the snap mounts 1471, thehandle of the multi-position valve 1712 is received in the adaptor 1464.The axial force associated with placing the multi-position valve 1712 inthe valve retainer 1469 is transmitted via the mating engagement betweenthe engagement structure 1473 on the valve retainer 1469 and thecircumferential edge 1474 on the adaptor 1464 to the shaft interface1446 and the base support member 1440. As the body of the multi-positionvalve is inserted into the valve retainer 1469, the body engages thedistal structure 1462 of the actuating member 1460, causing theactuating member 1460 to move proximally into the shaft interface 1446,with the spokes 1461 of the actuating member 1460 depressing or movinginto further engagement with the slots 1458 in the distal portion 1466of the shaft interface 1446. The axial proximal movement imparted to theactuating member 1460 causes the actuating member 1460 to operativelyassociate with the valve present sensor 1451, which initiates a valvepresent signal to the fluid control module and or injector 1300. Asshown in FIG. 22, the actuating member 1460 is preferably biased to anon-operative position relative to the valve present sensor 1451 by abiasing member or device such as a spring 1476, so that upon removal ofthe multi-position valve 1712 from the valve retainer 1469, theactuating member 1460 is moved automatically out of operativeassociation with the valve present sensor 1451.

Referring further to FIGS. 24A-26B and 24B-26B, the fluid level sensingmechanism 1406 (hereinafter “fluid level sensor 1406”) provided on thefluid control module 1400 is shown in greater detail. The fluid levelsensor 1406 generally interfaces with the drip chambers 1716 (or dripchambers 1716′) associated with the primary and secondary fluidcontainers 1704, 1706. The fluid level sensor 1406 is provided toindicate to the operator of the fluid delivery system 1200 thatsufficient injection fluid, either primary contrast media or secondarysaline, is available for an injection or flushing procedure. The fluidlevel sensor 1406 is generally adapted to indicate to warn the operatorwhen the fluid level in the drip chambers 1716 is below a levelsufficient to conduct an injection procedure. The fluid level sensor1406 is provided as a safety feature to ensure that air is notintroduced into the fluid path set 1700 during an injection procedure orflushing procedure involving the fluid delivery system 1200.

The fluid level sensor 1406 generally includes a support plate 1480, adrip chamber support 1482, and one or more fluid level sensors 1484(“hereinafter fluid sensors 1484”) which are adapted for associationwith the drip chambers 1716 connected to the primary and secondary fluidcontainers 1704, 1706. The support plate 1480 generally supports thevarious components of the fluid level sensor 1406. The drip chambersupport 1482 is generally secured to the support plate 1480 by suitablemechanical fasteners 1485 or another suitable attachment or mountingscheme. The drip chamber support 1482 is preferably a unitary structurethat is integrally molded of plastic material, and includes a pluralityof attachment or support locations 1486 adapted to support the dripchambers 1716. In particular, the drip chamber support 1482 includessnap mounts or positions 1488 for securing the bodies 1734 of the dripchambers 1716 in the fluid level sensor 1406, and operatively associatedwith the fluid sensors 1484. The snap mounts 1488 may be adapted toengage inlet and outlet ports of the drip chambers 1716, as shown inFIG. 26A.

The drip chamber support 1482 defines respective openings 1490 forreceiving the fluid sensors 1484, and associating the fluid sensors 1484with the drip chambers 1716. The openings 1490 are positioned to allowthe fluid sensors 1484 to be operatively associated with the projection1740 formed on the bodies 1734 of the respective drip chambers 1716. Asshown in FIG. 26A, the fluid sensors 1484 may physically contact theprojections 1740 on the drip chambers 1716, when the drip chambers 1716are secured in the support locations 1486 on the drip chamber support1482. The fluid sensors 1484 may be optical or ultrasonic sensors. Asuitable ultrasonic sensor for the fluid sensors 1484 is manufactured byOmron. A gasket 1492 may be provided between the drip chamber support1482 and the support plate 1480 to prevent fluid intrusion between thedrip chamber support 1482 and the support plate 1480, which could damagethe fluid sensors 1484. Indicator lights 1494 may be associated with thesupport locations 1486 to illuminate the drip chambers 1716. Theindicator lights 1494 are further adapted to visually indicate when thefluid level in the drip chambers 1716 drops to an unsafe level duringoperation of the fluid delivery system 1200, for example by changingmodes to an intermittent mode and blinking to indicate to the operatorthat insufficient fluid is available for an injection procedure. Theindicator lights 1494 provide “back-lighting” for not only the dripchambers 1716 but also the medical tubing associated with the dripchambers 1716, and light the medical tubing and drip chambers 1716 in,such a manner that the medical tubing and the drip chambers 1716 form a“light pipe” that illuminates at least part if not all of the firstsection 1710 of the fluid path set 1700. The back lighting allows theoperator of the fluid delivery system 1200 to easily visually inspectthe drip chambers 1716 to check the fluid level present in the dripchambers 1716.

The fluid sensors 1484 are generally adapted to provide fluid levelsignals to the computer hardware/software associated with the fluidcontrol module 1400 and/or injector 1300 to indicate the fluid levels inthe drip chambers 1716. The fluid sensors 1484 may be further adapted toinitiate an alarm signal to the computer hardware/software associatedwith the fluid control module 1400 and/or the injector 1300 when thefluid level in the drip chambers 1716 falls to an unsafe level. Thecomputer hardware/software associated with the fluid control module 1400and/or the injector 1300 may be adapted to respond to the alarm signalby halting the on-going injection procedure.

As FIG. 26A illustrates, the fluid sensors 1484 are tilted or angled ata slight or small angle relative to a vertical axis generally parallelto, the face of the support plate 1480. The slight angle, for example3°, is selected to complement the projection 1740 on the bodies 1734 ofthe drip chambers 1716. The projection 1740 on the bodies of the dripchambers 1716 is preferably tapered at a small angle, such as 3°. Theprojection 1740 on the bodies 1734 of the drip chambers 1716 ispreferably tapered inward at a small angle from the top end. 1736 to thebottom end 1738 on the drip chambers 1716, as illustrated in FIG. 26A.The fluid sensors 1784 are positioned in the openings 1490 to complimentthe tapered projections 1740 on the respective drip chambers 1716, andpreferably physically contact the projections 1740 as indicatedpreviously.

In FIG. 9B, fluid level sensor 1406 is configured in a manner tointerface with the tubing forming output lines 1718 above priming bulbsP, the priming volume defined by priming bulbs P, or fluid entrytubing/tubing connections C with output lines 1718 used to connect thepriming bulbs P with the output lines 1718. In the illustratedembodiment, snap mounts 1488 are eliminated in favor of the fluidsensors 1484 providing physical support for the fluid entrytubing/tubing connections C connecting the priming bulbs P with theoutput lines 1718 and, thereby, the priming bulbs P themselves. Fluidsensors 1484 are operable, depending of the sensed location, todetermine the presence or absence of fluid in output lines 1718, thepriming bulbs P themselves, or the fluid entry tubing/tubing connectionsC connecting the priming bulbs P with the output lines 1718 and, thus,the presence or absence of fluid in the priming bulbs P. Priming bulbs Pshown in FIGS. 9B and 10B are operable in a conventional manner todisplace air bubbles from the medical tubing forming output lines 1718and desirably displace a volume greater than the volume between thepriming bulbs P and spikes 1717.

As shown in FIGS. 9A-9B, the fluid control module 1400 includes aperistaltic pump 1408 that is associated with the secondary fluidcontainer 1706. The peristaltic pump 1408, or an equivalent device, isused to deliver fluid from the secondary fluid container 1706 to apatient typically between fluid injections from the primary fluidcontainer 1704, which are delivered via the syringe 1702 and theinjector 1300. The peristaltic pump 1408 is generally adapted to delivera set flow rate of the secondary fluid, for example saline, to thepatient via the second section 1720 of the fluid path set 1700. Theperistaltic pump 1408 may be a conventional pump known in the art.

The details of the peristaltic pump 1408 are shown in FIGS. 9A-9B, 27,and 28. Generally, the peristaltic pump 1408 includes a pump head 1496,a base plate 1497 for mounting the pump head 1496 to the front portionor side 1426 of the housing 1402, and an enclosure or door structure1498 for enclosing the pump head 1496. Mechanical fasteners 1499 may beused to secure the pump head 1496 to the base plate 1497, and mayfurther be used to secure the base plate 1497 to the front side 1426 ofthe housing 1402.

As shown in FIGS. 20 and 21, the front side 1426 of the housing 1402preferably includes opposing guides 1500, 1502 located above and belowthe peristaltic pump 1408 for securing medical tubing generally used toconnect the secondary fluid container 1706 to the second section 1720 ofthe fluid path set 1700 via the peristaltic pump 1408. In particular,with particular reference to FIGS. 10A-10B, the output line 1718 fromthe drip chamber 1716 associated with the secondary fluid container 1706is associated with the peristaltic pump 1408, and may be secured inoperative engagement with the peristaltic pump 1408 using the opposingguides 1500, 1502. The guides 1500, 1502 may be integrally formed withthe front side or portion 1426 of the housing 1402 and generally defineL-shaped slots 1503, which are generally adapted to receive the medicaltubing forming the output line 1718. FIGS. 9A-9B illustrate the use ofthe guides 1500, 1502, with the medical tubing extending from thesecondary fluid container 1706 and associated with peristaltic pump 1408received in the guides 1500, 1502 in accordance with the presentinvention. The door structure 1498 of the peristaltic pump 1408 may beadapted to prevent gravity flow from the secondary fluid container 1706when the peristaltic pump 1408 is not in operation, and further securesthe output line 1718 in operative association with the pump head 1496,as is conventional in the art.

Referring further to FIG. 28, the shut-off or pinch valve 1410 of thefluid control module 1400 is shown. The pinch valve 1410 is provideddownstream of the peristaltic pump 1408 and is used as back-up fluidshut-off mechanism to discontinue fluid flow to the second section 1720of the fluid path set 1700 when the peristaltic pump 1408 ceasesoperation. The pinch valve 1410 is adapted to open for fluid flow duringoperation of the peristaltic pump 1408, and is further adapted toautomatically close when the peristaltic pump 1408 ceases operation toprevent air from being introduced into the second section 1720 of thefluid path set 1700. The pinch valve 1410 generally prevents gravityflow to the second section 1720 of the fluid path set 1700 when theperistaltic pump 1408 is not in operation, and is generally provided asa back-up shut-off mechanism to the peristaltic pump 1408. The pinchvalve 1410 may be a conventional pinch valve, such as that manufacturedby Acro Associates. The pinch valve 1410 is mounted to the front side orportion 1426 of the housing 1402 by a bracket 1504 and mechanicalfasteners 1505. A gasket 1506 may be used to seal the connection betweenthe pinch valve 1410 and the front side or portion 1426 of the housing1402.

Referring further to FIGS. 29-31, the air detector assembly 1412 of thefluid control module 1400 is shown in greater detail. The air detectorassembly 1412 is adapted to detect gross air columns that may be presentin the output line 1718 connected to the drip chamber 1716 associatedwith the secondary fluid container 1706, and the output line 1719associated with the multi-position valve 1712. The air detector assembly1412 is generally adapted to initiate a signal to the computerhardware/software associated with the fluid control module 1400 and/orinjector 1300, if gross air is detected in the medical tubing formingthe output line 1719 associated with the multi-position valve 1712 or inthe medical tubing forming the output line 1718 and further associatedwith the peristaltic pump 1408. The fluid control module 1400 andinjector 1300 are preferably adapted to discontinue any on-going fluidinjection procedures if the air detector assembly 1412 detects gross airin the output line 1718 or the output line 1719.

The air detector assembly 1412 generally includes a sensor section 1508and a retaining device 1510 for securing the medical tubing forming theoutput line 1718 and output line 1719. The sensor section 1508 generallyincludes two air column detectors 1512 adapted to detect the presence ofgross air in the medical tubing secured by the retaining device 1510.The air column detectors 1512 may be conventional air detectors such asthose manufactured by Zevex. The sensor section 1508 may be secured tothe retaining device 1510 with mechanical fasteners 1513.

The retaining device 1510 is generally adapted to secure the medicaltubing forming the output line 1718 and output line 1719 in operativeassociation with the air column detectors 1512. The retaining device1510 generally includes a base 1514 and a closure assembly 1516associated with the base 1514. The sensor section 1508 is secured to thebase 1514 with the mechanical fasteners 1513. The base 1514 defines twofront openings 1518 for receiving the air column detectors 1512 andassociating the air column detectors 1512 with the medical tubing. Theair column detectors 1512 each define a recess 1520 for receiving themedical tubing, as shown in FIG. 30.

The closure assembly 1516 is generally adapted to secure the engagementof the medical tubing in the recesses 1520 in the air column detectors1512. The closure assembly 1516 is formed by two closure members ordoors 1522, which are generally adapted to move from a closed positionsecuring the medical tubing in the recesses 1520, to an open positionpermitting removal or disengagement of the medical tubing from therecesses 1520. The closure members 1522 are pivotally connected to thebase 1514 by pins 1524, and are preferably biased to the open positionby respective torsion springs 1526 associated with the pins 1524. Theclosure members 1522 may include projections 1528 that cooperate atleast partially with the recesses 1520 in the air column detectors 1512to secure the medical tubing in the recesses 1520 when the closuremembers 1522 are in the closed position. The closure members 1522 arepreferably formed of a substantially clear plastic material to permitviewing of the medical tubing in the recesses 1520 when the closuremembers 1522 are in the closed position.

A releasable locking mechanism or device 1530 may be associated with theretaining device 1510 for securing the closure members 1522 in theclosed position. The locking mechanism 1530 is provided to counteractthe biasing force of the torsion springs 1526. The locking mechanism1530 includes two sliders 1532 that are spring-loaded by a spring 1533.The closure members 1522 generally engage the sliders 1532, as shown inFIG. 30, and push against the spring-force to allow the closure members1522 to move past the sliders 1532, and then allow the sliders 1532 toengage the closure members 1522 to hold the closure members 1522 in theclosed position. The sliders 1532 may be retracted against thespring-force by two buttons 1534 located on opposing sides of the base1514. By depressing the buttons 1534, the sliders 1532 are retracted,which allows the closure members 1522 to spring open under the biasingforce of the torsion springs 1526. A cover plate 1535 may enclose thesliders 1532 of the locking mechanism 1530.

The base 1514 may include recessed structures 1536 located below thefront openings 1518 that are adapted to engage the first and secondconnector members 1774, 1776 of the connectors 1708 in the fluid pathset 1700 when the closure members 1522 are in the closed position. Inparticular, the closure members 1522 generally secure the first andsecond connector members 1774, 1776 to the recessed structures 1536 whenthe closure members 1522 are in the closed position, thereby preventingtheir movement when the first and second connector members 1774, 1776being joined and allowing one-handed connection of these parts. Therecessed structures 1536 are adapted to engage the bodies of the firstand second connector members 1774, 1776, so that first and secondconnector members 1774, 1776 in the connectors 1708 of the fluid pathset 1700 may be joined or connected with a one-handed operation. Thus,the recessed structures 1536 are generally adapted to prevent rotationof the first and second connector members 1774; 1776 when engaged withthe recessed structures 1536, so that the corresponding matingcomponents to be connected to the “engaged” first or second connectormember 1774, 1776 may be joined to the engaged first or second connectormember 1774, 1776 without having to use two hands to manipulate theopposing connecting members.

The installation and operation of the fluid delivery system 1200 willnow be discussed. Prior to turning on the fluid delivery system 1200, asource of power, such as 110 or 220 volts of electricity sent through aline cord from a wall socket (not shown) is provided to the fluiddelivery system. 1200. Thereafter, the operator turns on a master powerswitch (not shown), preferably situated on either the fluid controlmodule 1400 or the injector 1300 of the fluid delivery system 1200. Thefluid delivery system 1200 responds through visual indicia, such as theillumination of a green light (not shown) on the fluid control module1400 or the injector 1300, to indicate that the fluid delivery system1200 is in a powered-up state. The operator then turns on the userdisplay 210 (See FIG. 2) via a user display switch (not shown). It is tobe understood that the user display 210 may be turned on prior to thefluid delivery system 1200. After power has been supplied to the userdisplay 210, the fluid delivery system 1200 responds by undergoingvarious self-diagnostic checks to determine if the fluid delivery system1200 exhibits any faults or conditions that would prevent properoperation of the fluid delivery system 1200. If any of theself-diagnostic checks fail and/or a fault is detected in the fluiddelivery system 1200, a critical error window or screen is displayed onthe user display 210, which may instruct the operator to contact servicepersonnel to remedy the fault or instruct the operator on how to remedythe fault himself or herself. Additionally, the fluid delivery system1200 will not allow an operator to proceed with an injection if any ofthe self-diagnostic checks have failed. However, if all self-diagnosticchecks are passed, the fluid delivery system 1200 proceeds to display amain control screen on the user display 210.

The main control screen includes various on-screen controls, such asbuttons, that may be accessed by the operator via the touch-screen ofthe user display 210. The on-screen controls may include, but are notlimited to, selectable options, menus, sub-menus, input fields, virtualkeyboards, etc. The operator may therefore utilize the touch-screen ofthe user display 210 to program one or more injection cycles of thefluid delivery system 1200, and to display performance parameters. It isto be understood that input to the user display 210 may also beaccomplished by providing an on-screen cursor and external pointingdevice, such as a trackball or mouse, that is operatively associatedwith the on-screen cursor. It is to be understood that the operator maystop any automatic functions of the fluid delivery system 1200 bytouching an “Abort” button or anywhere on the user display 210.

Desirably, the main control screen includes a “New Case Setup” button,that when touched, initiates a “New Case Setup” screen to be displayedon the user display 210. In a practical sense, a “new case” isrepresentative of one or more injections for a specific patient and,therefore, having specific parameters inputted and associated therewith.The operator touches the “New Case Setup” button and, subsequently, theresultant “New Case Setup” screen displays a “Multi-Patient Syringe”button. After touching the “Multi-Patient Syringe” button, the operatoris presented with a screen displaying a “Retract” button and an “EngagePlunger” button displayed thereon. The operator touches the “Retract”button and the fluid delivery system 1200 retracts the piston associatedwith the injector 1300. The operator may then remove the syringe 1702from its package, orient the syringe 1702 to fit the pressure jacketassembly of the injector 1300, and place the syringe 1702 into thepressure jacket of the pressure jacket assembly. During the course ofthe syringe installation, the “Multi-Patient Syringe” screen remains onthe user display 210. Thus, after loading the syringe 1702 properly inthe pressure jacket assembly, the operator touches the “Engage Plunger”button, which causes the injector piston to move forward. The fluiddelivery system 1200 continues to move the injector piston forward untilthe injector piston engages the syringe plunger in the syringe 1702, andmechanically locks thereto. An audible clicking noise is produced toindicate a secure coupling between the injector piston and the syringeplunger. Thereafter, the syringe plunger travels the length of thesyringe 1702 to the distal end of the syringe 1702. The fluid deliverysystem 1200 may provide visual feedback of this action to the operatorvia the user display 210. Thereafter, the operator rotates the injectorhead of the injector 1300 into an upright position to allow any air tocollect at the distal end of the syringe 1702 when the syringe 1702 issubsequently filled. The user display 210 then reverts to the “New CaseSetup” screen.

The fluid delivery system 1200 is now ready to accept the installationof the first section 1710 of the fluid path set 1700. Specifically, theoperator removes the first section 1710 from its package. The firstsection 1710 is preferably provided in a sterile condition in thepackage. The operator then touches a “Multi-Patient Section” button,which causes the user display 210 to show an image of the fluid controlmodule 1400, bottle holders (i.e., primary and secondary fluidcontainers 1704, 1706), and injector 1300, with an overview of the firstsection 1710 highlighted in relation to these components. Additionally,the user display 210 also displays an “Install Saline” and an “InstallContrast” button. The operator touches the “Install Saline” button,which causes an enumerated list of actions corresponding to enumeratedsections of the image relating to the first section 1710 of the fluidpath set 1700, and connecting the first section 1710 to the secondaryfluid container 1706, which typically contains saline. This enumeratedlist may include, but is not limited, to actions such as (1) Installsaline tubing (which is depicted as a button); (2) Spike saline; (3)Fill drip chamber; and (4) Finish with saline. Thereafter, the fluidcontrol module 1400 opens the pinch valve 1410. Next, the operatorinstalls the saline container (i.e., secondary fluid container 1706).The operator now installs the drip chamber 1716 associated with thesecondary fluid container 1706 into place, and then opens theperistaltic pump 1408. The operator then routes the medical tubingforming the output line 1718 from the drip chamber 1716 through theperistaltic pump 1408 into the pinch valve 1410 and into the airdetector assembly 1412. Then, the operator closes the peristaltic pump1408. The text on the “Close Saline Tubing” button changes to read“Install Saline Tubing.” Then, the operator spikes the secondary fluidcontainer 1706 with spike 1717, fills the drip chamber 1716 by squeezingor “priming” it, and touches a “Complete” button. The fluid controlmodule 1400 now closes the pinch valve 1410. The user display 210 mayprovide visual indicia, such as a darkening of the saline portion, toindicate that the saline installation is completed successfully. Then,the operator touches the “Install Contrast” button, which causes anenumerated list of actions corresponding to enumerated sections of theimage relating to the contrast to be displayed. This enumerated list mayinclude, but is not limited to actions such as: (1) Install contrast(which is depicted as a button); (2) Attach high pressure line (i.e.,input line 1721) to syringe; (3) Spike contrast; (4) Fill drip chamber;and (5) Finish with contrast. Accordingly, the operator hangs thecontrast bottle (i.e., primary fluid container 1704) and touches the“Install Contrast” button. Thereafter, the fluid control module 1400turns the valve actuator 1404 to the inject position. The operator nowinstalls the drip chamber 1716 associated with the primary fluidcontainer 1706 in place in the fluid level sensing mechanism 1406, themulti-position valve 1712 in the valve retainer 1469 in the housing1470, and the output line 1718 in the air detector assembly 1412. Then,the operator closes the air detector assembly 1412. Thereafter, theoperator attaches the high pressure input line 1721 to themulti-position valve to the syringe 1702. Next, the operator spikes theprimary fluid container 1704, fills the drip chamber 1716 by squeezingor “priming” it, and touches a “Complete” button. The user display 210may provide visual indicia, such as a darkening of the contrast portion,to indicate that the contrast installation is completed. It is to beunderstood that the installation of the “contrast portion” and “salineportion” of the first section 1710 may be performed in parallel insteadof serially. Furthermore, the order of installation between the contrastportion and the saline portion of the first section 1710 may bereversed. Moreover, the internal sequence for installing the contrastportion and the saline portion may vary in numerous ways in accordancewith the present invention.

The syringe 1702 may now be initially filled with contrast media fromthe primary fluid container 1706. Specifically, the operator touches a“Fill Contrast” button on the user display 210, which causes the fluiddelivery system 1200 to enter an auto-fill mode, and to place themulti-position valve 17.12 in the fill position. After verifying thatthere is sufficient contrast media in the contrast drip chamber 1716 toinitiate the fill process, the fluid delivery system 1200 moves theinjector piston proximally at a controlled rate, such as 3 mL/s, whichcauses contrast media to be drawn from the primary fluid container 1704.The fluid delivery system 1200 may provide visual feedback of thisaction to the operator via the user display 210. Thus, the fluiddelivery system 1200 may display on the user display 210 the currentvolume in the syringe 1702 based upon the position of the injectorpiston. The fluid delivery system 1200 proceeds to draw contrast until apredetermined event occurs, such as the total remaining volume in thesyringe 1702 reaches a preset or pre-chosen amount or the contrast mediavolume in the primary fluid container 1706 is depleted completely. Themulti-position valve 1712 is then turned to the closed or isolateposition by the fluid delivery system 1200.

The fluid delivery system 1200 is now configured to undergo a purge ofany air in the tubing of the first section 1710 of the fluid path set1700. Specifically, the operator removes the protective caps 1798 fromthe first section 1710. Thereafter, the operator touches a “PurgeContrast” button on the “New Case Setup” screen, which causes the fluiddelivery system 1200 to move the multi-position valve 1712 to the injectposition. Then, the fluid delivery system 1200 moves the injector pistonforward at a predetermined rate, such as 1.0 to 1.5 mL/s, which causesany gas or liquid to be discharged from the syringe 1702, and the firstsection 1710. The operator ensures that the discharged fluid is caughtmanually in a suitable container. After the operator is satisfied thatall or most of the visible air is discharged, the operator touches the“Purge Contrast” button again to stop the purge. However, if theoperator does not manually stop the purge, the fluid delivery system1200 may stop the purge automatically, for example, once 5 mL of liquidor air is purged, based upon the relative injector piston movement. Theoperator may facilitate the removal of any remaining trapped air bytapping the body of the pressure jacket, joints, valves, and medicaltubing in the first section 1710. It is to be understood that thepurging operation may be repeated as necessary to ensure that all air isexpelled from the syringe 1702 and the first section 1710. Thereafter,the operator touches a “Complete” button, which causes themulti-position valve 1712 to move to the closed or isolate position,thereby stopping the flow of contrast media. The fluid delivery system1200 then causes the user display 210 to return to the “New Case Setup”screen. The operator may now install a new set of protector caps 1798 tothe exposed ends of the first section 1710.

The fluid delivery system 1200 now may undergo a purge of any air in thesaline portion of the first section 1710. Specifically, the operatortouches a “Purge Saline” button on the “New Case Setup” screen, whichcauses the fluid delivery system 1200 to open the pinch valve 1410, andturn on the peristaltic pump 1408. Saline from the secondary fluidcontainer 1706 begins to flow at a predetermined flow rate, such as 1.25mL/s, which causes any gas or liquid to be discharged from the firstsection 1710. The operator ensures that the discharged fluid is caughtmanually in a suitable container. After the operator is satisfied thatall or most of the visible air is discharged, the operator touches the“Purge Saline” button again to stop the purge. However, if the operatordoes not manually stop the purge, the fluid delivery system 1200 maystop the purge automatically after, for example, 5 seconds have passedsince the initiation of the purge. The operator may facilitate theremoval of any remaining trapped air by manually tapping the joints,valves, and tubing in the first section 1710. It is to be understoodthat the purging operation may be repeated as necessary to ensure thatsubstantially all air, particularly gross air, is expelled from thefirst section 1710. Thereafter, the operator touches a “Complete”button, which causes the user display 210 to return to the “New CaseSetup” screen. It is to be understood that the order of purging thecontrast and saline portions of the first section 1710 may be reversed.

At this point, the fluid delivery system 1200 is ready to accept theinstallation of the second section 1720 of the fluid path set 1700.Specifically, the operator removes the protector caps 1798 from thefirst section 1710 and removes the second section 1720 from its package.Then, the operator may secure the patient end of the second section 1720to an imaging table or other securing point. The operator then removesthe protector caps 1798 from the second section 1720. Thereafter, theoperator connects the connectors 1708 associated with the first andsecond sections 1710, 1720 to fluidly connect these sets or sections. Inparticular, the operator attaches the male connector of the low-pressuresaline tubing to the female connector of the first section 1710 andattaches the female contrast connector of the high-pressure contrasttubing to the male connector of the first section 1710. It is to beunderstood that the order of connecting the low pressure saline tubingand the high pressure contrast tubing to their respective connectors1708 may be reversed. The operator may now optionally place a sterilecover (not shown) on the user display 210 to maintain a sterileenvironment.

The fluid delivery system 1200 is now configured to undergo a purge ofany air in both the contrast portion (i.e., contrast lines), and salineportion, (i.e., saline lines), of the first section 1710 and the secondsection 1720. To purge the air in the contrast portion, the operatorremoves a cap (not shown) on the pressure isolation port 1761. Theoperator then touches the “Purge Contrast” button on the user display210, which causes the fluid delivery system 1200 to move themulti-position valve 1712 to the inject position. The contrast begins toflow through the contrast tubing, to fill the pressure isolationmechanism 1722, and then to flow out of the pressure isolation port1761. The operator then touches the “Purge Contrast” button again tostop the purge. However, if the operator does not manually stop thepurge, the fluid delivery system 1200 may stop the purge automatically,once a predetermined amount, for example 5 mL, of fluid or air ispurged, based upon the relative piston movement. When the purge iscomplete, the fluid delivery system 1200 moves the multi-position valve1712 to the closed position. The operator then attaches a pressuretransducer (See FIGS. 7B-7F) or line to the pressure isolation port1761. The operator initiates a contrast purging by touching the “PurgeContrast” button on the user display 210, which causes the fluiddelivery system 1200 to move the multi-position valve 1712 to the injectposition. The contrast begins to flow through the pressure isolationport 1761 and pressure transducer. Subsequently, the operator turns thetransducer multi-position valve 1712 to the inject position. The fluiddelivery system 1200 then moves the injector piston forward at apredetermined rate, such as 1.0 to 1.5 mL/s, which causes any gas orliquid to be discharged from the syringe 1702, first section 1710, andthe second section 1720. The operator ensures that the discharged fluidis caught manually in a suitable container. After the operator issatisfied that all or most of the visible gross air is discharged, theoperator touches the “Purge Contrast” button again to stop the purge.However, if the operator does not manually stop the purge, the fluiddelivery system 1200 may stop the purge automatically, once apredetermined amount, for example 5 mL, of fluid or air is purged, basedupon the relative piston movement. When the purge is complete, the fluiddelivery system 1200 moves the multi-position valve 1712 to the closedposition. The operator may facilitate the removal of any remainingtrapped air by manually tapping the pressure isolation mechanism 1722,connectors, valves, and tubing in both the first section 1710 and thesecond section 1720, and adjusting the second multi-position valve 1730as necessary. It is to be understood that the purging operation may berepeated as necessary to ensure that all gross air has been expelledfrom the fluid path set 1700.

To purge the air in the saline portion, the operator touches the “PurgeSaline” button, which causes the fluid delivery system 1200 to open thepinch valve 1410 and turn on the peristaltic pump 1408. Saline from thesecondary fluid container 1706 begins to drip at a predetermined flowrate, such as 1.25 mL/s, which causes any air in the saline portion ofthe fluid path set 1700 to be expelled. The operator ensures that thedischarged saline is manually caught in a suitable container. After theoperator is satisfied that all or most of the visible air is discharged,the operator touches the “Purge Saline” button again to stop the purge.However, if the operator does not manually stop the purge, the fluiddelivery system 1200 may stop the purge automatically after, forexample, 5 seconds have passed since the initiation of the purge. Theoperator may facilitate the removal of any remaining trapped air bymanually tapping the various components of the fluid path set 1700 inthe manner discussed previously. It is to be understood that the purgingoperation may be repeated as necessary to ensure that all air isexpelled from the fluid path set 1700. Thereafter, the operator touchesthe “Complete” button, which causes the display to return to the “NewCase Setup” screen. It is to be understood, that the order of purgingthe contrast portion and then the saline portion of the fluid path set1700, may be reversed.

The fluid delivery system 1200 may be configured to allow an operator topurge the contrast and saline portions of the fluid path set 1700 lineby utilizing the hand controller 400 as opposed to solely utilizing theon-screen controls. Furthermore, it is to be understood that the handcontroller 400 may be connected to the fluid control module 1400 at anytime during the installation of the fluid delivery system 1200.Specifically, the connector end of the hand controller connector securesto the hand controller plug of the fluid control module 1400. Connectionof the hand controller 400 may cause an icon representing the connectedhand controller 400 to be displayed on the user display 210. A preferredembodiment of the hand controller 400 is disclosed in U.S. PatentApplication Publication No. 2005/0273056, the contents of which areincorporated herein by reference in its entirety.

With reference to FIG. 34-36, the operator may utilize a setup wizardinterface 1801 to aid in the installation and operation of the fluiddelivery system 1200. Specifically, the setup wizard interface 1801allows the operator of the fluid delivery system 1200 to followgraphical representations and textual instructions concerning theinstallation of various components and steps to be followed in ensuringproper operation of the fluid delivery system 1200. The exemplary setupwizard interface 1801 is accessed from the main control screen and isdisplayed on the user display 210. The setup wizard interface 1801 maybe divided into distinct portions, such as a graphical portion 1802, aninstructional portion 1804, and an individual component and processsetup portion 1806. The individual component and process setup portion1806 may include a series of on-screen buttons such as a “Multi-PatientSyringe” button, a “Multi-Patient Section” button, and a “Single PatientSection” button, relating to respective components of the fluid deliverysystem. Additionally, the individual component setup and process setupportion 1806 may include another series of buttons such as a “FillSyringe” button, a “Purge Contrast” button, and a “Purge Saline” button,relating to respective processes of the fluid delivery system 1200.Desirably, each of these buttons maintains a series of correspondinginstructions associated therewith, that display within the instructionalportion 1804 of the setup wizard when the respective button is selected.The instructions displayed within the instructional portion 1804 mayalso reference related portions of the fluid delivery system 1200, orparts thereof that are graphically depicted within the graphical portion1802. Furthermore, the instructions of the instructional portion 1804may also contain embedded buttons associated with other instructions forcomponents or installation procedures related thereto. When theseadditional buttons are selected, the instructions associated therewithare then displayed in the same instructional portion 1804. For example,if the operator selects an “Install Saline Tubing” 1808 button, as shownin FIG. 35, the instructions associated therewith, namely: (1) Installdrip chamber; (2) Open pump door; (3) Install saline line; (4) Closepump door; (5) Spike saline bag; and, (6) Fill drip chamber, appearwithin the instructional portion 1804, as shown in FIG. 36. Theinstructional portion 1804 may also display related tips, warnings, oradvisements. For example, a message informing the operator that thepatient must be disconnected prior to engagement of the plunger,displays beneath the “Engage plunger” instruction, as shown in FIG. 34.

As shown in FIGS. 34-36, the setup wizard interface 1801 is laid outsuch that certain instructional portions 1804 of the pre-injection setupsequence may be bypassed depending upon the operator's familiarity withthe setup of the fluid delivery system 1200. Thus, the operator need notfollow the instructions provided by the setup wizard interface 1801 in alinear fashion. For example, a novice operator may want to proceedlinearly with the instructions for setup, whereas a more skilledoperator may want to view only instructions regarding setup of specificcomponents and installation steps of the fluid delivery system 1200. Thesetup wizard interface 1801, therefore, efficiently conveys therequisite information for proper setup of the fluid delivery system 1200to operators of various degrees of familiarity and knowledge of thefluid delivery system 1200.

Once the necessary components of the fluid delivery system are properlyinstalled, the operator of the fluid delivery system 1200 may administereither a fixed rate injection or a variable rate injection inconjunction with a saline flush delivery. The user display allows theoperator to input various data relating to each type of injection to beadministered. Additionally, the user display 210 preferably providesvisual and/or audio feedback during the delivery of the contrast in theinjection cycle including, but not limited to, values corresponding tothe flow rate, volume, and pressure limit relating to that particularinjection cycle. It is to be understood that values displayed on thedisplay 210 unit may be dynamic, such that with each varying plungerdepression of the hand controller 400, new values for the flow rate,volume, and pressure limit may be displayed on the user display.

The fluid delivery system 1200 provides for various modes of refillingthe syringe once the fluid delivery system 1200 determines that there isinsufficient contrast media to perform an injection. A full automatictype refill is defined as a refill that occurs after the initial fillingof the syringe 1702. The full automatic type of refill automaticallyfills the syringe 1702 with a maximum volume of contrast media that thesyringe 1702 may hold, for example, 150 mL. Thus, in a full automatictype refill, refill commands are automatically given from the userdisplay 210 without any operator intervention. A predetermined automatictype of refill fills the syringe 1702 with a predetermined operatorspecified volume, for example 25, 50, 75, or 100 mL. Thus, if there isinsufficient contrast in the syringe 1702 to complete the nextinjection, the operator is prompted for permission by the user displayas to whether or not the fluid delivery system should be allowed toinitiate a refill to the predetermined volume. A manual type of fillallows the operator to fill the syringe 1702 by utilizing the on-screencontrols, whenever the operator deems a refill to be necessary. Thus, amanual type fill includes a start and stop refill function associatedtherewith. However, the manual fill is still subject to programming ofthe fluid delivery system 1200 and the operator, in the manual fillmode, will be selecting from a menu of fill levels rather than anindependently chosen level. Prior to each injection, the operator mayindicate to the fluid delivery system 1200 which refill type is to beused when additional contrast is required to finish an injection. Once arefill type is selected, the refill type remains in place until changedby the operator. In an exemplary embodiment, the operator may touch a“Protocol” button on the main control screen to display a protocolscreen with an “Options” button displayed thereon. The operator touchesthe “Options” button, which causes a list of options to appear, such asa “Refill Type” button. After touching the “Refill Type” button, theoperator is typically presented with three refill types, namely (1) FullAutomatic, for example to 150 mL; (2) Predetermined, for example 25, 50,75, or 100 mL; and, (3) Manual. If the operator selects the fullautomatic refill, then a pop-up window confirming the automatic refillrequest may appear. If the operator selects the predetermined refill, alist of fill volumes appears, which requires the operator to choose fromone of the fill volumes. Desirably, the fill volumes are listed inmanageable 25 mL increments, as an example. If the operator selects themanual refill, then a pop-up window confirming the manual refill requestmay appear. Once the operator is satisfied with using a particularrefill type for the instant injection cycle, the operator may thenconfirm the use of this refill type by touching another confirmationbutton, such as an “OK” button.

The fluid delivery system 1200 may maintain pre-programmed fluiddelivery programs, (i.e., protocols), stored therein. Thus, instead ofmanually entering the desired flow rate, volume, pressure limit, risetime, and optionally delay for each injection cycle, the operator mayprogram and store protocols, and recall previously stored protocolscorresponding to injection elements, such as the desired flow rate,volume, pressure limit, rise time, and optionally delay. In an exemplaryembodiment, a protocol is programmed and recalled via the on-screencontrols of the user display 210. Specifically, the operator navigatesto the protocol screen by touching, for example, the “Protocol” button,if not there already. Thereafter, the operator touches a “Fixed Flow” or“Variable Flow” mode button, which indicates whether a protocol relatingto a fixed or variable flow injection, respectively, will be programmed.It is to be understood that not all injection elements may be changed bythe operator when entering values relating to the variable flowinjection.

A pop-up window confirming the request to enter into programming modemay appear, which requires the operator to confirm the request. Theoperator then touches a flow rate button. Visual indicia, such asinversing the color of the button, may indicate that indeed this or anybutton was touched by the operator. A parameter range for the allowableflow rate is displayed, along with the virtual numeric keyboard forentering the flow rate. The operator enters the desired flow rate andmay touch a confirmation button, such as “Enter” to confirm the enteredflow rate. Next, the operator touches a volume button. A parameter rangefor the allowable volume is displayed, along with the virtual numerickeyboard for entering the volume. The operator enters the desired volumeand may confirm the volume by touching the “Enter” button. Then, theoperator touches a pressure limit button. A parameter range for theallowable pressure range is displayed, along with the virtual numerickeyboard for entering the pressure. The operator enters the desiredpressure and may confirm the pressure by touching the “Enter” button.Then, the operator touches a “Rise” button. A parameter range for theallowable rise time is then displayed, along with the virtual numerickeyboard for entering the rise time. The operator enters the rise timeand may confirm the rise time by touching the “Enter” button. It is tobe understood that any of the above values be entered in varying orders.The fluid delivery system 1200 is programmed to alert the operator if arequested command or entered value is outside the predefined parameters.This alert may be accomplished through either audio or visual indicia,such as a beep or an on-screen alert message, respectively.

After entering the appropriate values for a protocol, the operator maystore the protocol into any available memory position of the fluiddelivery system 1200 for future use of the protocol in other injectioncycles with other patients. Specifically, the operator touches a “Store”button. The virtual alphanumeric keyboard for entering a name for thecorresponding protocol is displayed. The operator may enter anappropriate name and confirm the name by touching the “Enter” button.

The operator may recall any previously stored protocol from the memoryof the fluid delivery system 1200. For example, the operator maynavigate to the protocol screen by touching a “Protocol” button, if notalready there. Thereafter, the operator touches a “Recall” button. Thefluid delivery system displays a screen showing all available, saved,preprogrammed protocols. The operator may recall, or select any of theprotocols by touching the corresponding button of the protocol.Accordingly, the fluid delivery system displays the values associatedwith that particular protocol, as previously stored in memory. If theoperator is satisfied with using this protocol for the instant injectioncycle, the operator may confirm the use of this protocol by touchinganother confirmation button, such as an “OK” button.

Once the appropriate protocol is selected and is initiated with thefluid delivery system 1200, the corresponding fixed rate injection or avariable rate injection may be performed. It is to be understood thateither the fixed rate or the variable rate injections may be performedby the hand controller 400. Alternatively, injections may be performeddirectly through the on-screen controls of the user display 210,bypassing the need for the hand controller 400 or the foot pedal.

In an exemplary embodiment, the fixed rate injection is initiated by theoperator by depressing the plunger on the hand controller 400.Subsequently, the air detector assembly 1412 turns on and begins tomonitor for any air within the lines. The multi-position valve 1712rotates to the inject position. The injector piston accelerates to aprogrammed rate in the rise time allotted. The contrast media flowsuntil either the operator releases the plunger or the programmed volume,as specified by the protocol, is delivered. After any of theseconditions has been met, the injector piston ceases forward movement.Then the multi-position valve 1712 rotates to a closed or isolateposition preferably after a set period of time to allow residualcontrast media to exit the syringe 1702, and the air detector assembly1412 enters into a sleep-mode.

In an exemplary embodiment, the variable rate injection is initiated bythe operator by depressing the plunger on the hand controller 400.Subsequently, the air detector mechanism 1412 turns on to monitor forany air within the lines. The multi-position valve 1712 rotates to theinject position. The injector piston moves forward corresponding to apercentage of an acceleration rate as determined by the position of theplunger of the hand controller 400. The contrast flows until either theoperator releases the plunger or the programmed volume, as specified bythe protocol, is delivered. After any of these conditions is met, theinjector piston ceases forward movement. Thereafter, the multi-positionvalve 1712 preferably remains open for a preset or predetermined amountof time, to allow residual contrast media to exit the syringe 1702.Then, the multi-position valve 1712 rotates to a closed position. If theentire programmed volume is delivered in a variable flow rate mode, thenthe injector 1300 rearms. If the operator releases the hand controlleractuating member or assembly before the entire programmed volume isdelivered, the multi-position valve 1712 remains open for thepredetermined amount of time and then closes. It is to be understoodthat at the end of each variable rate injection, the fluid deliverysystem 1200 creates a sharp bolus within the contrast tubing downstreamof the multi-position valve 1712, by suppressing the delivery ofcontrast media that is not delivered at the programmed flow rate. Asharp bolus of contrast media may be defined as a distinct or definedcolumn of liquid having well-defined opposing ends or boundaries.However, the creation of the sharp bolus results in pressure buildupupstream of the multi-position valve 1712. To remove the excesspressure, the multi-position valve 1712 may have a simple vent forexpelling liquid and relieving the excess pressure. Alternatively, theinjector piston may be moved slowly backward or proximally in acontrolled manner, so that no vacuum is created in the contrast tubing,and so that no audible sound, such as a whizzing sound, is produced.Desirably, this result is accomplished by having the fluid deliverysystem 1200 turning the voltage applied to the injector head motor onand off in short increments, thereby creating a controlled sequence ofrelease/stop movements of the injector piston until the pressure in thesyringe 1702 is equalized. After the pressure drops to the systemfriction of the fluid delivery system 1200, which is mostly comprised ofthe static friction between the syringe plunger and the syringe 1702 andthe internal mechanical components of the injector head of the injector1300, the fluid delivery system 1200 is ready for another injection.This process is repeated until the programmed volume has been delivered.Thereafter, the air detector assembly 1412 enters into a sleep-mode.

The saline flush delivery or injection may be performed at any timeduring the injection cycle, except when contrast is flowing. In anexemplary embodiment, initiating the saline injection requires theoperator to depress the saline actuator or saline button of the handcontroller 400. Subsequently, the air detector assembly 1412 of thefluid control module 1400 turns on to monitor for any air in the medicaltubing associated with the saline portion of the fluid path set 1700.The pinch valve 1410 retracts to allow for the flow of saline from thesecondary fluid container 1706. The fluid delivery system 1200 may beconfigured to permit the flow of saline until the operator releases thesaline button on the hand controller 400, presses the saline buttonagain, or until a predetermined amount of time lapses from theinitiation of the flow of saline. The saline flow stops once movement inthe peristaltic pump 1408 ceases. Thereafter, the pinch valve 1410 movesto a closed position and the air detector assembly 1412 enters into asleep-mode.

During either the fixed rate injection cycle or the variable rateinjection cycle, the fluid delivery system 1200 may display aninstantaneous average value for a corresponding flow rate, fluidpressure, volume delivered for the most recent individual injectionwithin the injection cycle, and a cumulative volume delivered to thepatient, up to and including, the most recent injection. At theconclusion of the delivery, the fluid delivery system 1200 may display apeak flow rate, a peak fluid pressure, a volume delivered for the mostrecent individual injection within the injection cycle, and a cumulativevolume delivered to the patient during the entire delivery.

It is to be understood that the fluid delivery system may exist ineither an armed or unarmed state, which corresponds respectively towhether or not the operator is allowed to perform an injection. Thefluid delivery system 1200 may enter a disarmed or safe state whencertain conditions are met including, but not limited to, failure of aself-diagnostic check, detection of air in either the contrast or salineportions of the fluid path set 1700, absence of some of the requisitecomponents, and the reaching of a pressure limit that is deemed to beunsafe for the patient. The converse of these conditions and/or otherfactors must be present for the fluid delivery system 1200 to enter thearmed state. The fluid delivery system 1200 may provide various visualand/or audible alarms to the operator to identify specific conditionsthat arise during the functioning of the fluid delivery system 1200.Such conditions may include, but are not limited to the arming/disarmingof the fluid delivery system 1200 and the state thereof, the detectionof air in the fluid path, the insufficiency or unavailability of fluidin the fluid delivery path or fluid supply to perform an injection, andthe reaching of a pressure disarm limit.

With reference to FIGS. 32 and 33 and with continuing reference to FIG.9, the support assembly 1600 of the fluid delivery system 1200 includesa support arm 1602 for supporting the control section 1800 and the userdisplay 210 in particular. A second support arm 1604 extends from asupport column 1606 that generally supports the injector and fluidcontrol module 1400. The support arms 1602, 1604 are associated with arail interface 1608 which is generally adapted to attach the fluiddelivery system 1200 to a hospital bed or examination table 1610. Thesupport column 1606 may include a pedestal interface 1612 for attachingthe fluid delivery system 1200 to, a movable pedestal 1614. As shown inFIG. 32, the fluid delivery system may either be attached to theexamination table 1610 or the movable pedestal 1614 to provide themaximum amount of flexibility and ease in utilizing the fluid deliverysystem 1200. Thus, when the fluid delivery system 1200 is mounted to theexamination table 1610, a rail mount 1616 is attached to a rail 1618 ofthe examination table 1610. This allows the rail interface 1608 to beremovably attached to the rail mount 1616. Thus, the rail mount 1616indirectly supports the user display 210, the injector 1300, and thefluid control module 1400. In an alternative embodiment, as shown inFIG. 33, only the injector 1300 and the fluid control module 1400 areindirectly supported by the rail mount 1616, and an additional railmount 1616 may be utilized to independently support the user display 210at a different location on the rail 1618 of the examination table 1610.Returning to FIG. 32, the movable pedestal 1614 provides mobility to thefluid delivery system 1200 and height adjustability features. Themovable pedestal 1614 includes a pedestal interface mount 1620 extendingtherefrom, for attaching the pedestal interface 1612 to the movablepedestal 1614. The pedestal interface mount 1620 may be configured tointerface with electrical connections from the pedestal interface 1612.The movable pedestal 1614 further includes a base 1622 for holding loosecomponents related to the fluid delivery system 1200 and the powercables associated therewith. A handle 1624 provides access to theinterior of the base 1622. The base 1622 may also include a power socket1626 that interfaces with the power cables (not shown) within the base1622. Thus, a single external power cable (not shown) may be pluggeddirectly into the power socket 1626 to provide sufficient power foroperation of the entire fluid delivery system 1200. The movable pedestal1614 may also include a plurality of casters 1628 having lockable brakes1630 and wheels 1632. A handle 1634 may be attached to the movablepedestal 1614 to facilitate movement of the fluid delivery system 1200.By aligning the rail interface 1608 over the rail mount 1616 and thenlowering the height of the movable pedestal 1614, the fluid deliverysystem 1200, may easily be transferred from the pedestal 1614 and to thebed 1610. It is to be understood that the aforementioned configurationsare not to be considered as limiting the placement and positioning ofthe fluid delivery system 1200.

Although the present invention has been described in detail inconnection with the above embodiments and/or examples, it is to beunderstood that such detail is solely for that purpose and thatvariations can be made by those skilled in the art without departingfrom the invention. The scope of the invention is indicated by thefollowing claims rather than by the foregoing description. All changesand variations that come within the meaning and range of equivalency ofthe claims are to be embraced within their scope.

The invention claimed is:
 1. A fluid delivery system, comprising: apressurizing device for delivering injection fluid under pressure; a lowpressure fluid delivery system; and a pressure isolation mechanismcomprising: a valve housing comprising a first port connected with anoutput of the pressurizing device, a second port connected with anoutput of the low pressure fluid delivery system, an outlet port forconnection to a patient, and a pressure isolation port for connectionwith a pressure transducer; a first valve contained in the valvehousing, the first valve having a normally open position permittingfluid communication between the first port and the second port andmovable to a closed position when a fluid pressure in the first portincreases to a predetermined pressure level, the first valve isolatingthe pressure isolation port and the second port from the first port whenin the closed position; and a second valve disposed in the second port,the second valve regulating a fluid flow through the second port.
 2. Thefluid delivery system of claim 1, wherein the first valve comprises abiasing portion biasing the first valve to the normally open position,and wherein the first valve is movable to the closed position when thefluid pressure in the first port reaches the predetermined pressurelevel to overcome a biasing force of the biasing portion.
 3. The fluiddelivery system of claim 2, wherein the first valve comprises a seatportion adapted to engage a seat structure in the valve housing todefine the closed position of the first valve.
 4. The fluid deliverysystem of claim 3, wherein the biasing portion is formed integrally withthe seat portion.
 5. The fluid delivery system of claim 1, wherein thesecond valve comprises a disk valve.
 6. The fluid delivery system ofclaim 5, wherein the disk valve comprises one or more passageways forregulating the fluid flow through the second port.
 7. The fluid deliverysystem of claim 6, wherein the one or more passageways comprises one ormore slits through a body of the disk valve.
 8. The fluid deliverysystem of claim 5, wherein the disk valve is secured in place in thesecond port by a sleeve.
 9. The fluid delivery system of claim 1,wherein the second valve regulates the fluid flow in both directions inthe second port.
 10. The fluid delivery system of claim 1, wherein thesecond valve permits the fluid flow through the second port when thefluid pressure increases to a predetermined pressure level in the secondport.
 11. A fluid delivery system, comprising: a pressurizing device forsupplying an injection fluid under pressure; a low pressure fluiddelivery system; a pressure isolation mechanism comprising a valvehousing with a first port connected to an output of the pressurizingdevice, a second port adapted for connection to a patient, and a thirdport connected to an output of the low pressure fluid delivery system,the pressure isolation mechanism comprising a first valve contained inthe valve housing and having a first state and a mutually exclusivesecond state, the first state occurring when the second and third portsare connected and the first and third ports are connected, and thesecond state occurring when the first and second ports are connected andthe first and third ports are disconnected, the first valve beingnormally in the first state and being switchable to the second statewhen a fluid pressure from the pressurizing device reaches apredetermined pressure level to isolate the second port and the thirdport from the first port; and a second valve disposed in the third portand regulating a fluid flow through the third port, wherein the valvehousing further comprises a pressure isolation port for a pressuretransducer.
 12. The fluid delivery system of claim 11, wherein the firstvalve comprises a biasing portion biasing the first valve to a normallyopen position, and wherein the first valve is movable to a closedposition when the fluid pressure from the pressurizing device reaches apredetermined pressure level to overcome a biasing force of the biasingportion.
 13. The fluid delivery system of claim 12, wherein the firstvalve comprises a seat portion adapted to engage a seat structure in thevalve housing to define the closed position of the first valve.
 14. Thefluid delivery system of claim 13, wherein the biasing portion is formedintegrally with the seat portion.
 15. The fluid delivery system of claim11, wherein the second valve comprises a disk valve.
 16. The fluiddelivery system of claim 15, wherein the disk valve comprises one ormore passageways for regulating the fluid flow through the third port.17. The fluid delivery system of claim 16, wherein the one or morepassageways comprises one or more slits through a body of the diskvalve.
 18. The fluid delivery system of claim 15, wherein the disk valveis secured in place in the third port by a sleeve.
 19. The fluiddelivery system of claim 11, wherein the second valve regulates thefluid flow in both directions in the third port.
 20. The fluid deliverysystem of claim 11, wherein the second valve permits the fluid flowthrough the third port when the fluid pressure reaches the predeterminedpressure level.
 21. A pressure isolation mechanism comprising: a valvebody comprising a first port, a second port, an outlet port, and apressure isolation port for a pressure transducer; a first valvecontained in the valve body and having a normally open positionpermitting fluid communication between the first port and the secondport, the first valve movable to a closed position when a fluid pressurein the first port increases to a predetermined pressure level, whereinthe first valve isolates the pressure isolation port and the second portfrom the first port when in the closed position; and a second valvedisposed in the second port for regulating a fluid flow through thesecond port.
 22. The pressure isolation mechanism of claim 21, whereinthe second valve comprises a disk valve.
 23. The pressure isolationmechanism of claim 22, wherein the disk valve comprises one or morepassageways for regulating the fluid flow through the second port. 24.The pressure isolation mechanism of claim 23, wherein the one or morepassageways comprises one or more slits through a body of the diskvalve.
 25. The pressure isolation mechanism of claim 22, wherein thedisk valve is secured in place in the second port by a sleeve.
 26. Thepressure isolation mechanism of claim 21, wherein the second valveregulates the fluid flow in both directions in the second port.
 27. Thepressure isolation mechanism of claim 21, wherein the second valvepermits the fluid flow through the second port when the fluid pressureincreases to the predetermined pressure level.